FDA.reportPublic FDA data

NDC 52959-457 - Gabazolamine-0.5

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
52959-457
Package NDCs from labels
52959-457-30
Manufacturer
Physician Therapeutics LLC | Sandoz Inc | H.J. Harkins Company, Inc | Targeted Medical Pharma Inc.
Effective date
2011-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabazolamine-0.5Physician Therapeutics LLC | Sandoz Inc | 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
52959-457-30Gabazolamine-0.530 in 1 BOTTLETABLET300.5 mg8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-457GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8Unmatched20110812_c4b5257a-4dfa-4a58-a05b-c0a32dbb9352.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CHOLINEACTIVE MOIETYN91BDP6H0XGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
GELATININACTIVE INGREDIENT2G86QN327LGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8

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 2 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
unii: F05Q2T2JA0
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
unii: F05Q2T2JA0
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMClinical Solutions Wholesale, LLC0cf8b567-201b-44fa-8fd3-c74023aff44f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
unii: F05Q2T2JA0
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
unii: F05Q2T2JA0
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESWALMART INC. (see also Equate)43fd4231-0962-4828-a3fa-a1faec81e43d2026-07-15WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
unii: F05Q2T2JA0
Laxative and Stool SoftenerDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)5be43e46-e49b-49eb-a95f-7c4577032f902026-07-13WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.800fa966-077d-4624-9e36-75fe8863dad02026-07-10WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.4203d3fe-916e-41af-9daf-f58f4fed6f9c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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