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 37 of 52 · 1,026 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: ETJ7Z6XBU4
Stool SoftenerDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)d4128fbd-32ba-4d2e-ae1a-cbe438f5b39b2024-07-31WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
unii: F05Q2T2JA0
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESGOOD SENSE17cdef7b-71bf-b4a6-e063-6294a90a5b742024-07-22WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.aaf7979c-168a-0da2-e053-2995a90a4d122024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074342
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.b43df4ca-8d28-7b3a-e053-2a95a90aa4d72024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074342
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx Pharmacy of Tennessee, LLCb39e2bc8-b691-0f4e-e053-2995a90a00fd2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services LLCb23e53d4-fd7d-452d-a851-35a143b6dcb42024-07-08WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack2c9a1fe7-b77b-436b-8701-9f95f642d0012024-07-05WarningsExact identifier
unii: F05Q2T2JA0
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
FleetDOCUSATE SODIUMC.B. Fleet Company, Inc.56a7b6c5-d674-4eed-91c2-77f7d18fff322024-06-27WarningsExact identifier
unii: F05Q2T2JA0
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMWALMART INC. (see also Equate)2cf6c9bf-c318-445d-9306-5675b1d424b02024-06-26WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWALMART INC. (see also Equate)d9db24b5-e3b5-47f9-b86b-bc8d70896a112024-06-26WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESTOP CARE (Topco Associates LLC)3b184800-649b-45d0-9586-8055d6d7fe082024-06-20WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerSTOOL SOFTENERGood Sense64266195-1b07-42c2-98a7-d76c12f747762024-06-18WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus StimulantDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI6c8c7c46-3ded-4e89-8e16-30eeb72aa08b2024-06-14WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI50ca1ce2-885f-4b71-a5fb-90c2cf508ce62024-06-14WarningsExact identifier
unii: F05Q2T2JA0
basic care stool softenerDOCUSATE SODIUMAmazon.com Services LLC356a889f-ec23-4eb2-a25c-bbe6094751552024-06-14WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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