NDC 52959-321 - Gabazolamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52959-321
Package NDCs from labels
52959-321-30
Manufacturer
Physician Therapeutics LLC | Actavis Elizabeth LLC | H.J. Harkins Company, Inc | Targeted Medical Pharma Inc.
Effective date
2011-08-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GabazolaminePhysician Therapeutics LLC | Actavis Elizabeth LLC | H.J. Harkins Company, Inc | Targeted Medical Pharma Inc.2011-08-18HUMAN PRESCRIPTION DRUG LABEL
Sentrazolam AM-0.25Physician Therapeutics LLC | Actavis Elizabeth LLC | H.J. Harkins Company, Inc | Targeted Medical Pharma, Inc.2011-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-321-30Gabazolamine30 in 1 BOTTLETABLET300.25 mg13
52959-321-30Sentrazolam AM30 in 1 BOTTLETABLET300.25 mg9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-321GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13Unmatched20110819_6224f2c5-8e3c-4bcf-a8c6-a97004d6f432.zip
52959-321SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9Unmatched20110812_3364cee6-0a88-47bb-9af8-8e90843de236.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CHOLINEACTIVE MOIETYN91BDP6H0XGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
GELATININACTIVE INGREDIENT2G86QN327LGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAZOLAMINE (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]13
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE MOIETYN91BDP6H0XSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENTRAZOLAM AM (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 39 of 52 · 1,026 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Occuloplex IEUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENEBioActive Nutritional, Inc.c2c9b577-4f75-4ddc-815f-46c3bb9b46d22024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
LymphoplusTRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEADeseret Biologicals, Inc.92f6fc6b-58c0-4137-88b3-bee2118aeb292024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.a1b42f4b-4029-4008-b950-a7725f34b43d2024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.04dfad30-9496-43c6-8ce8-ab04fdb9ce3b2024-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.ed20d198-e935-200e-e053-2a95a90a309b2024-05-02WarningsExact identifier
unii: F05Q2T2JA0
AI MiasmASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMEnergique, Inc.df829e4a-c982-4d02-b318-38b1fbc5072d2024-05-02WarningsExact identifier
unii: ETJ7Z6XBU4
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Stimulant laxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9467e1f7-19bb-4fb3-853b-75c4d28bb9a92024-05-01WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)72f8e8d7-ee38-4bd3-8711-f11fded0cede2024-05-01WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLCc1e9863a-c229-4694-b450-6b0e0ad375032024-04-30WarningsExact identifier
unii: F05Q2T2JA0
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.a98082ba-21ec-4cf8-b81c-bcb41eb9fd122024-04-23WarningsExact identifier
unii: ETJ7Z6XBU4
Stool Softener LaxativeDOCUSATE SODIUMQUALITY CHOICE (Chain Drug Marketing Association)96c7f8bc-be95-40d1-9977-44b7cc6582df2024-04-22WarningsExact identifier
unii: F05Q2T2JA0
LigaparLAPPA MAJOR, LIGAMENT (HUMAN), CARTILAGO SUIS, ARNICA MONTANA, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CAUSTICUM, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, ZINCUM METALLICUMEnergique, Inc.17f6b1f5-8e49-49df-bad4-9c19fa677e692024-04-22WarningsExact identifier
unii: ETJ7Z6XBU4
VisioparEUPHRASIA OFFICINALIS, EYE (SUIS), AURUM METALLICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, MAGNESIA CARBONICA, PHOSPHORUS, SILICEA, PHYSOSTIGMA VENENOSUM, OSMIUM METALLICUM, THUJA OCCIDENTALISEnergique, Inc.811f7626-0d21-49bd-8c31-9a5abec45c132024-04-19WarningsExact identifier
unii: ETJ7Z6XBU4
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: ETJ7Z6XBU4
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMH E B5b8bcc6c-de03-4d73-a76f-6f4c371cf2502024-04-09WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMH E B1dd2be7e-bdca-4e43-b853-3ed10b6366322024-04-08WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMBryant Ranch Prepack25781f50-d309-4c4f-9e21-c019e068d1012024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074342
rxcui: 308048
unii: YU55MQ3IZY
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack1f11cf85-b094-4ca4-8b48-2d3a9093304b2024-04-04WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.