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 15 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
unii: F05Q2T2JA0
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
unii: F05Q2T2JA0
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
unii: F05Q2T2JA0
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b2024-09-09WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESAmerisourceBergen (Good Neighbor Pharmacy) 461227e573645-b156-4768-8e69-00998f5080732024-09-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)7f4f7fcb-5202-4184-80ef-b4b6c6460c2f2024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5bdc4291-2565-49be-93f1-84f60f9831352024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4bcf2ea2-7de2-4b89-b7b4-e132457f8a812024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)19e10544-81f4-4c2d-8a63-238c562c2f5c2024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFIdb15be6e-9ac6-4cf9-89f8-14480c89fcd22024-09-04WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.f7e63d96-2310-4ab1-e053-6294a90a86fc2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
STOOL SOFTENER AND STIMULANT LAXATIVEDOCUSATE SODIUM AND SENNOSIDESTARGET CORPORATION7cac99da-8d89-0aee-e053-2991aa0a0fd92024-08-22WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
unii: F05Q2T2JA0
Sool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)7104b955-fadd-4ce7-9342-fb28027fc4a92024-08-12WarningsExact identifier
unii: F05Q2T2JA0
Senna S OrangeDOCUSATE SODIUM SENNOSIDESCare One (Retail Business Services, LLC.)3da76cb2-08c3-475d-9320-69450bbcf8cd2024-08-09WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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