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 46 of 52 · 1,026 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC54c790c5-2e6c-439d-8e3b-7502c962a5962023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b4fb-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
AlprazolamALPRAZOLAMHikma Pharmaceuticals USA Inc.b945ac6f-796e-41ef-85e9-61007e4a4e9a2023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
XanaxALPRAZOLAMPHARMACIA & UPJOHN COMPANY LLC388e249d-b9b6-44c3-9f8f-880eced0239f2023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALSab40b62b-9f8d-4394-92d5-09d9f1941eaa2023-01-16Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Gyno ComplexVIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Incdfaaa56a-4226-4f62-a219-d3f89fe7afe32023-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d367e5-e846-54ba-e053-2991aa0a63d42023-01-12Exact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
DALEKTRO NSILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDEPEKANA Natruheilmittel GmbH2b39ce30-54ff-4586-bda1-d9410140b26e2023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
AlprazolamALPRAZOLAMActavis Pharma, Inc.a23063c0-099a-4256-b95f-3a857bbf704b2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074342
ndc (product): 0228-2027
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
spl id: 08d09d46-386d-4dc8-a0c1-5711261c6282
spl set id: a23063c0-099a-4256-b95f-3a857bbf704b
unii: YU55MQ3IZY
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
KELANSILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOPPEKANA Naturheilmittel GmbH55786d99-ee1f-490f-9023-3e6c39da86b02022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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