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 5 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c2026-03-13WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreenscda27a9c-9175-4b07-9c0b-d8d8978829652026-03-12WarningsExact identifier
unii: F05Q2T2JA0
HEALIX SENNA-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGBrainstorm Industries LLC4cc5388f-1716-5d19-e063-6394a90a5a252026-03-11WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMAmerisource Bergen4caf0bcb-c1bf-0ae7-e063-6294a90a344b2026-03-10WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreens92df761b-da68-4ce9-b02a-a5a74fd6620e2026-03-10WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESWalgreensb03e1500-0a4f-4e3d-a897-d7781fd5f7912026-03-09WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce2026-03-06WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
unii: F05Q2T2JA0
Alprazolam C-IVALPRAZOLAM C-IVDirect_Rxf6dd8005-1d50-41bc-e053-6394a90ac45b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LPc6795ed8-af28-41f4-b85b-48e1fe9d03692026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
DOCUSATE SODIUMDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.5d300ea7-78eb-4e19-8333-1e42c73c4c542026-02-26WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMPreferredPharmaceuticals Inc.dc130aae-4510-4de7-a750-4a144e88208d2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.73c1d1dc-ade2-4bb4-b109-83bd63acd15c2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.78682252-e448-4b20-b49d-27c2c70e4cb32026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b2026-02-13WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)cb2698b1-6c58-417f-ae86-74fbe38146262026-02-03WarningsExact identifier
unii: F05Q2T2JA0
SENNA-SDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services, LLC905bd658-a0af-4f20-be3d-00c54868a26c2026-01-29WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMMeijer Distribution Inc.81edf0d8-b6f3-4b3a-85db-0108160756b12026-01-28WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED1ad73079-ebb3-dae7-e063-6294a90a05582026-01-28WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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