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 31 of 52 · 1,026 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeuropathEaseAGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEASilver Star Brands7809e54a-018d-9cf6-e053-2a91aa0aedfe2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Laxative Docusate Sodium with SennaDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCcf9075d8-e20e-419a-b996-9b12f49f05f22025-01-01WarningsExact identifier
unii: F05Q2T2JA0
Vegetable Laxative and Stool SoftnerDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCe84d693d-0041-4c11-8f6a-b5c332f79af92025-01-01WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb39e2bc8-b68f-0f4e-e053-2995a90a00fd2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074342
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb4cd647f-1ba3-334e-e053-2995a90af3522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074342
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCf667458d-ddda-4e9e-e053-2995a90adb5a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
LaxacinDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx Pharmacy of Tennessee, LLCfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2024-12-31WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMAmerican Health Packagingea95d182-453b-4c43-8402-d65c488d55f22024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
rxcui: 308048
unii: YU55MQ3IZY
DOCUSATE SODIUMDOCUSATE SODIUMA-S Medication Solutions946abcdb-96bd-43e6-992a-bb97679c00f02024-12-30WarningsExact identifier
unii: F05Q2T2JA0
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
unii: F05Q2T2JA0
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGRUGBY LABORATORIESf5afd8eb-d35d-44ab-897d-1d41c98ca1382024-12-19WarningsExact identifier
unii: F05Q2T2JA0
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGRUGBY LABORATORIES2e758ff1-3083-4245-8f58-1c47b042bfdd2024-12-19WarningsExact identifier
unii: F05Q2T2JA0
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Association4d5facd4-f57f-44f7-b8dd-83a33e57afd92024-12-18WarningsExact identifier
unii: F05Q2T2JA0
Good Neighbor Stool SoftenerDOCUSATE SODIUMAmerisourceBergen Drug Corp88d657a1-77be-412a-9295-034872db2dde2024-12-18WarningsExact identifier
unii: F05Q2T2JA0
Preferred Stool SoftenerDOCUSATE SODIUMReese Pharmaceutical Co217d13a0-3205-492c-af49-82eb80dba53a2024-12-18WarningsExact identifier
unii: F05Q2T2JA0
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC9342c1b5-5d35-4b60-b347-c208c0774cdc2024-12-18WarningsExact identifier
unii: F05Q2T2JA0
HEB Stool SoftenerDOCUSATE SODIUMH E B3a513cb9-8404-43dc-a780-040bf9f1741d2024-12-18WarningsExact identifier
unii: F05Q2T2JA0
Topcare Stool Softener laxativeDOCUSATE SODIUMTOPCO ASSOCIATES LLCf9302fc2-684d-4cc2-bdd7-7ad0e9304edb2024-12-18WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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