Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10066731serious1Date Last Updated24/04/2014receiptdateformat102companynumbUS-TMC-CABO 14004064occurcountryUSseriousnessother1duplicate1Date Received08/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age55Unit of Onset AgeyearsWeight106SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionPulmonary embolismOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionThrombosis in deviceOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPleural effusionOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionDehydrationOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionFood cravingOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionHiccupsOutcomeRecovering/resolving

7)

reactionmeddraversionpt17.0ReactionHypophagiaOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionOdynophagiaOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionNeck painOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionStomatitisOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCABOZANTINIBdrugbatchnumbL0402115drugauthorizationnumb203756drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb2700drugcumulativedosageunit003drugdosagetext60 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationMALIGNANT MELANOMAdrugstartdateformat102drugstartdate07/02/2014drugenddateformat102drugenddate23/03/2014actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA203756, NDA208692Brand NameCOMETRIQ, CABOMETYXGeneric NameCABOZANTINIBManufacturersExelixis, Inc.product_ndc42388-011, 42388-012, 42388-013, 42388-023, 42388-025, 42388-024Product TypeHUMAN PRESCRIPTION DRUGRXCUI 1363273, 1363279, 1363281, 1363284, 1363312, 1363408, 1363409, 1363410, 1364580, ... spl_id44348f65-cf41-4e9f-9735-a8e1d855bdde, 922fa6f9-ca92-4a91-bc9a-1a523a61b49aspl_set_id1a0c3bea-c87b-4d25-bb44-5f0174da6b34, 3850cce2-6137-42e5-a792-d318c4a4b3b5Package NDC 42388-011-14, 42388-012-14, 42388-013-14, 42388-023-26, 42388-023-36, 42388-023- ... UNIIDR7ST46X58RouteORALActive IngredientsCABOZANTINIB S-MALATE

2)

drugcharacterization1medicinalproductCABOZANTINIBdrugbatchnumbL0402115drugauthorizationnumb203756drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb2700drugcumulativedosageunit003drugdosagetext40 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate09/04/2014actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA203756, NDA208692Brand NameCOMETRIQ, CABOMETYXGeneric NameCABOZANTINIBManufacturersExelixis, Inc.product_ndc42388-011, 42388-012, 42388-013, 42388-023, 42388-025, 42388-024Product TypeHUMAN PRESCRIPTION DRUGRXCUI 1363273, 1363279, 1363281, 1363284, 1363312, 1363408, 1363409, 1363410, 1364580, ... spl_id44348f65-cf41-4e9f-9735-a8e1d855bdde, 922fa6f9-ca92-4a91-bc9a-1a523a61b49aspl_set_id1a0c3bea-c87b-4d25-bb44-5f0174da6b34, 3850cce2-6137-42e5-a792-d318c4a4b3b5Package NDC 42388-011-14, 42388-012-14, 42388-013-14, 42388-023-26, 42388-023-36, 42388-023- ... UNIIDR7ST46X58RouteORALActive IngredientsCABOZANTINIB S-MALATE

3)

drugcharacterization2medicinalproductLORAZEPAMdrugrecurreadministration3

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

4)

drugcharacterization2medicinalproductONDANSETRONdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA206846, ANDA079224, ANDA090648, ANDA078776, ANDA077851, ANDA076972, ANDA0769 ... Brand NameONDANSETRON, ZUPLENZ, ONDANSETRON HYDROCHLORIDEGeneric NameONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON TABLETSManufacturers Accord Healthcare, Inc., Heritage Pharmaceuticals, NorthStar Rx LLC, Eywa Pharma ... product_ndc 16729-298, 23155-547, 23155-549, 16714-671, 71930-017, 71930-018, 45963-538, 459 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsONDANSETRON, ONDANSETRON HYDROCHLORIDERXCUI 283504, 1740467, 312085, 198052, 312086, 998028, 998032, 998033, 998035, 104894, ... spl_id 58fbdc1b-69f5-58f3-e053-2991aa0a1a04, 4503b017-b020-41e2-b0e1-6602dc7e28f2, f821 ... spl_set_id 35e0d160-813f-41d7-a382-d2cab6485d9c, b746d4db-43e6-4219-9e6b-f53e59581305, ac3d ... Package NDC 16729-298-05, 23155-547-31, 23155-547-41, 23155-547-42, 23155-549-31, 16714-671- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNII4AF302ESOS, NMH84OZK2B

5)

drugcharacterization2medicinalproductOXYCODONEdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id faecea25-bf41-43c2-99de-89ba81a21162, 424fa63c-5bd6-457d-b65e-c40ddfc48d6c, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

6)

drugcharacterization2medicinalproductGABAPENTINdrugrecurreadministration3

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

7)

drugcharacterization2medicinalproductDRONABINOLdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA078292, ANDA079217, NDA018651, ANDA207421, NDA205525, ANDA201463Brand NameDRONABINOL, SYNDROS, MARINOLGeneric NameDRONABINOLManufacturers Rhodes Pharmaceuticals L.P., Akorn, Inc., Ascend Laboratories, LLC, AvKARE, Benu ... product_ndc 42858-867, 42858-868, 42858-869, 17478-761, 17478-762, 17478-763, 67877-568, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDRONABINOLRXCUI197634, 197635, 197636, 1928948, 1928954, 205641, 205642, 205645spl_id 5467a1be-b888-4f7c-9a62-5faf6c977b05, dc76bfc1-db41-459c-8401-512058213bb0, 39f1 ... spl_set_id 3c06ccda-4819-40f8-b2db-fa294bb8a2fa, a0409d82-a61e-4b9e-8717-ced299ccedb2, 0bb0 ... Package NDC 42858-867-06, 42858-868-06, 42858-869-06, 17478-761-06, 17478-762-06, 17478-763- ... NUIN0000175782, M0003267Established Pharmacologic ClassCannabinoid [EPC]Chemical StructureCannabinoids [CS]UNII7J8897W37S

8)

drugcharacterization2medicinalproductSERTRALINEdrugrecurreadministration3

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

9)

drugcharacterization2medicinalproductSENNAdrugrecurreadministration3

openFDA Info on Medication

Application Numberpart334Brand NameSENNAGeneric NameSENNA, SENNOSIDES, SENNA LEAFManufacturers Akron Pharma Inc., CVS Pharmacy, Boiron, TARGET Corporation, Advance Pharmaceuti ... product_ndc 71399-8237, 59779-586, 0220-4642, 11673-886, 17714-122, 0904-6434, 11822-6523, 6 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDES A AND B, SENNOSIDES, SENNA LEAFRXCUI702311, 312935, 476827spl_id a95e938e-ed52-4328-b339-2c0b63a66b03, e46c9628-21d2-423c-9eda-4ace626960a1, 8761 ... spl_set_id 9e9c434a-7075-45d4-b7b3-0f83a33cf046, c3ba17b9-e34a-496d-9bb9-cd5c19c79f92, 80b3 ... Package NDC 71399-8237-8, 59779-586-25, 59779-586-50, 0220-4642-41, 11673-886-01, 17714-122- ... UNII1B5FPI42EN, 3FYP5M0IJX, AK7JF626KX

10)

drugcharacterization2medicinalproductFENTANYLdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA022569, ANDA202097, ANDA077449, NDA021947, NDA202788, NDA019813, ANDA076258Brand NameLAZANDA, FENTANYL SYSTEM, FENTANYL, FENTORA, SUBSYS, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, Alvogen, Apotex Corp., Cephalon, Inc., Insys T ... product_ndc 71500-110, 71500-140, 71500-130, 47781-423, 47781-424, 47781-426, 47781-427, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, TRANSDERMAL, BUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 197696, 245134, 245135, 24 ... spl_id 9f5c9d6b-1f8a-0f2e-e053-2a95a90a1458, b9f82be8-5426-7518-e053-2995a90abd81, 4696 ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, 242759ef-cb6d-4e3e-9f8d-5e31efa1f289, 0ff7 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 47781-423-47, 47781-424-47, 47781-426- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

11)

drugcharacterization2medicinalproductFINASTERIDEdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA203687, ANDA090121, ANDA091643, ANDA090061, ANDA207750, ANDA078341, NDA02078 ... Brand NameFINASTERIDE, PROPECIA, PROSCARGeneric NameFINASTERIDEManufacturers Aurobindo Pharma Limited, Rising Health, LLC, Accord Healthcare, Inc., Camber Ph ... product_ndc 65862-927, 65862-686, 57237-061, 16729-090, 16729-089, 31722-525, 67877-455, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 310346, 213178, 201961spl_id 7f209776-8fde-4aac-b266-f342525ea9ca, 019ae597-49a2-40c1-b87a-e656f9c471fc, 42b2 ... spl_set_id 7d140366-2388-488e-bd86-67e6edf44345, 01b88593-99d3-4dd6-a7b6-5438c15bd7b7, adfb ... Package NDC 65862-927-30, 65862-927-90, 65862-927-99, 65862-686-30, 65862-686-90, 65862-686- ... NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

12)

drugcharacterization2medicinalproductTAMSULOSINdrugrecurreadministration3

13)

drugcharacterization2medicinalproductDIAZEPAMdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

14)

drugcharacterization2medicinalproductPOLYETHYLENE GLYCOLdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA091077Brand NameEASYLAX, OSMOTIC LAXATIVEGeneric NamePOLYETHYLENE GLYCOLManufacturersMarc Glassman, Inc., Lidl US, LLCproduct_ndc68998-465, 71141-140Product TypeHUMAN OTC DRUGRouteTOPICAL, ORALActive IngredientsPOLYETHYLENE GLYCOL 3350spl_idd1c545f2-a116-48cd-b04d-500a3c996012, aa19a516-b9bd-4e92-96ec-041031193c01spl_set_idc22fd883-7d17-43c6-8bae-5b669064db5d, a61acdee-7371-4ac1-8285-8b4fd023e42bPackage NDC68998-465-83, 71141-140-32NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5PRXCUI876193

15)

drugcharacterization2medicinalproductDEXAMETHASONEdrugrecurreadministration3

openFDA Info on Medication

Application Number NDA022315, ANDA088237, NDA211379, ANDA201270, ANDA088481, ANDA088254, NDA208912, ... Brand Name OZURDEX, TAPERDEX 12-DAY, HEMADY, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Acrotech Biopharma LLC, Levins Pharmaceutica ... product_ndc 0023-3348, 42195-149, 42195-490, 72893-015, 71905-400, 48102-045, 48102-046, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 2261802, 2286261, 2121587, 197577, 197 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, dff2b4b8-6dba-4bf3-ac9d-3960db623d1b, 20ec ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, aec6 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 72893-015-24, 72893-015- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

16)

drugcharacterization2medicinalproductDACARBAZINEdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA075812, ANDA075259, ANDA075371Brand NameDACARBAZINEGeneric NameDACARBAZINEManufacturers Hikma Pharmaceuticals USA Inc., Teva Parenteral Medicines, Inc., Fresenius Kabi ... product_ndc0143-9245, 0703-5075, 63323-127, 63323-128Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsDACARBAZINERXCUI1731338, 1731340spl_id aac851c5-8ca2-4b13-87cb-f8f78b1f2cbc, 83fa961b-7275-4e85-9047-e956c63316da, 9b00 ... spl_set_id 0d81315c-7021-4091-b703-ad135390c936, 26e91082-7698-4680-beab-07c47802f0f9, b6b9 ... Package NDC 0143-9245-01, 0143-9245-10, 0703-5075-01, 0703-5075-03, 63323-127-10, 63323-128- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNII7GR28W0FJI

17)

drugcharacterization2medicinalproductREGLANdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA017854Brand NameREGLANGeneric NameMETOCLOPRAMIDE HYDROCHLORIDEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-165, 62559-166Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOCLOPRAMIDE HYDROCHLORIDERXCUI207265, 207266, 311666, 311668spl_id06daee34-5164-4630-af92-bc43fa9c295dspl_set_idde55c133-eb08-4a35-91a2-5dc093027397Package NDC62559-165-01, 62559-166-01UNIIW1792A2RVD

18)

drugcharacterization2medicinalproductOMEPRAZOLEdrugrecurreadministration3

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

19)

drugcharacterization2medicinalproductMAGNESIUMdrugrecurreadministration3

openFDA Info on Medication

Brand NameMAGNESIUM METALLICUMGeneric NameMAGNESIUMManufacturersWashington Homeopathic Productsproduct_ndc71919-432, 68428-981Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUMspl_id7e576a9a-5338-06b5-e053-2a91aa0a87b5, f66824cf-f8b0-4a71-b798-821343c5a77bspl_set_idce81f9c8-da78-43dd-a255-46978ec47d9c, 458aa1da-e975-4e11-a0c0-5ce352046ae1Package NDC 71919-432-07, 71919-432-08, 71919-432-09, 71919-432-10, 68428-981-03, 68428-981- ... UNIII38ZP9992A

20)

drugcharacterization2medicinalproductDOCUSATEdrugrecurreadministration3

Report Duplicate

duplicatesourceEXELIXISduplicatenumbUS-TMC-CABO 14004064

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use