Adverse Event Report

Report

reporttype2Version of Safety Report ID6receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11320794serious1Date Last Updated08/06/2016receiptdateformat102companynumbUS-ACTELION-A-NJ2015-121379occurcountryUSseriousnessother1duplicate1Date Received29/07/2015seriousnesshospitalization1transmissiondate15/08/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age50Unit of Onset Ageyearspatientagegroup5Weight156.1SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionDyspnoeaOutcomeUnknown

2)

reactionmeddraversionpt19.0ReactionWeight increasedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.0ReactionChronic kidney diseaseOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.0ReactionAcute kidney injuryOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.0ReactionLoss of consciousnessOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt19.0ReactionSputum culture positiveOutcomeRecovered/resolved

7)

reactionmeddraversionpt19.0ReactionBronchitisOutcomeRecovered/resolved

8)

reactionmeddraversionpt19.0ReactionUrinary tract infectionOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt19.0ReactionPyrexiaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt19.0ReactionHaemoptysisOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt19.0ReactionSepsisOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt19.0ReactionWoundOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductOXYGEN.drugrecurreadministration3

activesubstance

activesubstancenameOXYGEN

openFDA Info on Medication

Brand Name OXYGEN COMPRESSED U.S.P, OXYGEN REFRIGERATED LIQUID U.S.P, OXYGEN, MEDICAL OXYGE ... Generic NameOXYGEN, 0XYGENManufacturers Apria Healthcare LLC, In Home Medical, Inc., NLR Welding Supply, Inc., AGL Inhal ... product_ndc 51319-072, 51319-073, 60941-001, 62045-4333, 17575-001, 19979-000, 23650-001, 51 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASAL, CUTANEOUSActive IngredientsOXYGENRXCUI 312173, 312172, 542304, 348831, 312174, 348381, 348017, 312175, 311998, 899761, ... spl_id 92e3d064-473a-4e09-bfa1-7306c4aef38f, b12e14c8-af49-4578-e053-2a95a90a6532, d595 ... spl_set_id 105a5557-c1af-42b1-859e-76cc1e83d9aa, 2260d92d-9a68-4e4f-a4bf-c6961851fdda, 49d5 ... Package NDC 51319-072-01, 51319-072-02, 51319-072-03, 51319-072-04, 51319-072-05, 51319-072- ... UNIIS88TT14065, N762921K75Application Number NDA205849, NDA205865, NDA205767, NDA206023, NDA205889, NDA212314, NDA205712, NDA ...

2)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

3)

drugcharacterization2medicinalproductNOVOLOGdrugdosagetext100 U/ML, UNKdrugrecurreadministration3

activesubstance

activesubstancenameINSULIN ASPART

openFDA Info on Medication

Application NumberBLA020986Brand NameNOVOLOGGeneric NameINSULIN ASPARTManufacturersNovo Nordiskproduct_ndc0169-3303, 0169-7501, 0169-6339, 0169-6338, 0169-2001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsINSULIN ASPARTRXCUI311040, 351926, 1653196, 1653198, 1653202, 1653204spl_id952147fd-80b2-481b-bc17-e94ac49f1bb1spl_set_id3a1e73a2-3009-40d0-876c-b4cb2be56fc5Package NDC 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339- ... NUIM0011417, N0000175453Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin Analog [EPC]UNII059QF0KO0R, D933668QVX

4)

drugcharacterization2medicinalproductHUMALOGdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 U/ML, TIDdrugrecurreadministration3

activesubstance

activesubstancenameINSULIN LISPRO

openFDA Info on Medication

Application NumberBLA021017, BLA020563, BLA205747, BLA021018Brand Name HUMALOG MIX75/25, HUMALOG MIX75/25 KWIKPEN, HUMALOG KWIKPEN, HUMALOG, HUMALOG J ... Generic NameINSULIN LISPROManufacturersEli Lilly and Companyproduct_ndc 0002-7511, 0002-8797, 0002-8799, 0002-7510, 0002-7516, 0002-7712, 0002-7714, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, INTRAVENOUSActive IngredientsINSULIN LISPRORXCUI 259111, 752388, 847252, 847254, 242120, 865098, 1652239, 1652242, 1652639, 16526 ... spl_id b2994f24-d275-417a-a5a1-0997652e9091, 4d586487-399b-43f6-9050-dd1a1a270bcf, eceb ... spl_set_id c73da51a-1899-45ad-b6cf-9c52c36a25dd, c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f, b34c ... Package NDC 0002-7511-01, 0002-7511-99, 0002-8797-01, 0002-8797-59, 0002-8797-99, 0002-8797- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNIIGFX7QIS1II

5)

drugcharacterization2medicinalproductLORATADINE.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameLORATADINE

openFDA Info on Medication

Application Number ANDA210722, ANDA076471, ANDA076301, ANDA202538, ANDA076805, ANDA075209, ANDA0757 ... Brand Name LORATADINE, ALLERGY RELIEF, CHILDRENS LORATADINE SUGAR FREE, COUNTERACT ALLERGY, ... Generic NameLORATADINE, LORATADINE ORALManufacturers Granules India Ltd, Geri-Care Pharmaceutical Corp, Shopko Stores Operating Co., ... product_ndc 62207-787, 57896-788, 37012-612, 69452-211, 69842-540, 54473-166, 36800-608, 036 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINE, FAMOTIDINERXCUI 311372, 828269, 692783, 1087051, 311373, 665078, 744830, 206805, 1020126, 755478 ... spl_id 9aadc2f2-d0ea-5297-e053-2995a90ac51e, 9aa07ca9-ee19-89c7-e053-2a95a90ae9b5, 105d ... spl_set_id 0dee9036-d51f-4d7f-b5e2-4f6940249eef, 41fab408-35cb-47cc-bd4e-bba4ec10f6c7, 47b0 ... Package NDC 62207-787-51, 62207-787-59, 57896-788-03, 57896-788-09, 37012-612-65, 37012-612- ... UNII7AJO3BO7QN, 5QZO15J2Z8NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

6)

drugcharacterization2medicinalproductLANTUSdrugdosagetext100 U/ML, UNKdrugrecurreadministration3

activesubstance

activesubstancenameINSULIN GLARGINE

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUSGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2220, 0088-2219, 0088-5021, 0088-5020Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN GLARGINERXCUI285018, 311041, 847230, 847232spl_id0a57f187-f101-4268-851f-7f20c7f708f9, 4e455ace-94f4-4fa3-85eb-0152e5a06239spl_set_idd5e07a0c-7e14-4756-9152-9fea485d654a, 6328c99d-d75f-43ef-b19e-7e71f91e57f6Package NDC 0088-2220-33, 0088-2220-34, 0088-2219-00, 0088-2219-01, 0088-2219-05, 0088-5021- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ

7)

drugcharacterization2medicinalproductMETOLAZONE.drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameMETOLAZONE

openFDA Info on Medication

Application NumberANDA076698, NDA017386, ANDA076466, ANDA076732, ANDA213251Brand NameMETOLAZONEGeneric NameMETOLAZONEManufacturers Mylan Pharmaceuticals Inc., Lannett Company, Inc., Eon Labs, Inc., Alembic Pharm ... product_ndc 0378-6172, 0378-6173, 0378-6174, 0527-2215, 0527-2216, 0527-2217, 0185-0055, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOLAZONERXCUI197978, 197979, 311671spl_id 6e3e9170-70e3-4642-9c40-a23e5a18a5f3, b6f3bb5c-c896-44d9-88be-eef3a89b1724, 3d77 ... spl_set_id 6639d111-eb21-4997-b964-f5c61bc088f2, 7276cfbf-294d-464d-b8f4-e33da8a15658, 0b61 ... Package NDC 0378-6172-01, 0378-6173-01, 0378-6174-01, 0527-2215-37, 0527-2216-37, 0527-2217- ... NUIN0000175359, N0000175420Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide-like Diuretic [EPC]UNIITZ7V40X7VX

8)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

9)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019090Brand NameZANTACGeneric NameRANITIDINE HYDROCHLORIDEManufacturersTeligent, Inc., Teligent Pharma, Inc.product_ndc52565-096, 52565-101, 52565-102Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDERXCUI104084, 312772, 1859553, 1859554spl_id4a3400a1-5ac0-407f-b4c9-cc75b5da4b82, f893211b-dae4-417b-8d5a-e4f54d0d3833spl_set_id95dc4515-7690-4881-ae14-9f8655a68dfe, c1b12354-9409-4e76-bcdc-024c190d6583Package NDC52565-096-04, 52565-101-25, 52565-102-05UNIIBK76465IHM

10)

drugcharacterization2medicinalproductSOTALOL.drugstructuredosagenumb160drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext160 MG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameSOTALOL

openFDA Info on Medication

Application NumberANDA207428Brand NameSOTALOLGeneric NameSOTALOL HYDROCHLORIDEManufacturersBayshore Pharmaceuticals LLCproduct_ndc76385-114, 76385-115, 76385-116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOTALOL HYDROCHLORIDERXCUI1923422, 1923424, 1923426spl_id6d091d32-9a0e-45ad-a9a1-35dc92dbe8a0spl_set_id56879738-8662-4f5c-8386-761ab2b5e46fPackage NDC 76385-114-01, 76385-114-50, 76385-115-01, 76385-115-50, 76385-116-01, 76385-116- ... UNIIHEC37C70XX

11)

drugcharacterization2medicinalproductDEPO-PROVERAdrugdosagetext150 MG/ML, UNKdrugrecurreadministration3

activesubstance

activesubstancenameMEDROXYPROGESTERONE ACETATE

openFDA Info on Medication

Application NumberNDA020246Brand NameDEPO-PROVERAGeneric NameMEDROXYPROGESTERONE ACETATEManufacturersPharmacia & Upjohn Company LLCproduct_ndc0009-0746, 0009-7376Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsMEDROXYPROGESTERONE ACETATERXCUI1000126, 1000128, 1000153, 1000154spl_id8088c906-ead8-4afb-965a-599ff3ae1919spl_set_id199cf13e-0859-4a73-9b45-e700d0cd1049Package NDC0009-0746-30, 0009-0746-35, 0009-7376-11UNIIC2QI4IOI2G

12)

drugcharacterization2medicinalproductMETOPROLOL.drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameMETOPROLOL

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

13)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

14)

drugcharacterization1medicinalproductTRACLEERdrugauthorizationnumb021290drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext125 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationPULMONARY ARTERIAL HYPERTENSIONdrugstartdateformat102drugstartdate17/08/2012actiondrug1

activesubstance

activesubstancenameBOSENTAN

openFDA Info on Medication

Application NumberNDA021290, NDA209279Brand NameTRACLEERGeneric NameBOSENTANManufacturersActelion Pharmaceuticals US, Inc.product_ndc66215-101, 66215-102, 66215-103Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBOSENTANRXCUI349253, 352066, 656659, 656660, 1989081, 1989085spl_id93c78d0b-c8ba-4ef4-b3c9-43d6d198a70dspl_set_id749e42fb-2fe0-45dd-9268-b43bb3f4081cPackage NDC 66215-101-06, 66215-101-03, 66215-102-06, 66215-102-03, 66215-103-14, 66215-103- ... UNIIQ326023R30

15)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

16)

drugcharacterization2medicinalproductSPIRONOLACTONE.drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, NDA012151, ANDA089424, ANDA20593 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, 9590 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

17)

drugcharacterization2medicinalproductHYDROMORPHONEdrugstructuredosagenumb8drugstructuredosageunit003drugdosagetext8 MG, PRNdrugrecurreadministration3

activesubstance

activesubstancenameHYDROMORPHONE

18)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, PRNdrugrecurreadministration3

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

19)

drugcharacterization2medicinalproductZOFRANdrugstructuredosagenumb4drugstructuredosageunit003drugdosagetext4 MG, UNKdrugrecurreadministration3

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

20)

drugcharacterization2medicinalproductAMITIZAdrugstructuredosagenumb8drugstructuredosageunit004drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext8 MCG, BIDdrugrecurreadministration3

activesubstance

activesubstancenameLUBIPROSTONE

openFDA Info on Medication

Application NumberNDA021908Brand NameAMITIZAGeneric NameLUBIPROSTONEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-080, 64764-240Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLUBIPROSTONERXCUI616578, 617768, 794639, 794641spl_id13cd7c3a-6e60-4f2d-a588-eb452fc711d0spl_set_idd474ac6a-444d-4aa6-9986-24be6fcf811dPackage NDC64764-080-60, 64764-240-60, 64764-240-10NUIN0000175573, N0000175456Established Pharmacologic ClassChloride Channel Activator [EPC]Mechanism of ActionChloride Channel Activators [MoA]UNII7662KG2R6K

21)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugstructuredosagenumb.275drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.275 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

22)

drugcharacterization2medicinalproductRANITIDINE.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, QDdrugrecurreadministration3

activesubstance

activesubstancenameRANITIDINE

openFDA Info on Medication

Application Number ANDA091429, NDA021698, ANDA076195, ANDA200172, ANDA207579, ANDA207578, ANDA07865 ... Brand Name COOL MINT ACID REDUCER, ZANTAC MAXIMUM STRENGTH 150 COOL MINT, HARRIS TEETER ACI ... Generic NameRANITIDINE, RANITIDINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Boehringer Ingelheim Pharmaceuticals Inc., Harris Teeter, ... product_ndc 11822-0950, 0597-0120, 69256-876, 37808-303, 69842-293, 41520-609, 58602-733, 58 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDE, RANITIDINERXCUI 198191, 827189, 312773, 198193, 1090518, 705610, 643046, 198190, 198192, 827183, ... spl_id 0ebab972-16c7-4733-b1bc-e063d53f9e87, 97cb5218-4c7e-5ae5-e053-2995a90af3f2, a43a ... spl_set_id 4784c5b2-58eb-4b7c-b6e9-13dde7610a37, 888d9feb-fc9b-49cc-8361-30b5da86ea05, a43a ... Package NDC 11822-0950-1, 11822-0950-0, 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120- ... UNIIBK76465IHM, 884KT10YB7NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

summary

narrativeincludeclinicalCASE EVENT DATE: 20150709

Report Duplicate

duplicatesourceACTELIONduplicatenumbUS-ACTELION-A-NJ2015-121379

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use