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 14 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
unii: F05Q2T2JA0
SENNA-PLUSSENNOSIDES AND DOCUSATE SODIUMGeri-Care Pharmaceutical Corp8a0882ed-f623-2359-e053-2995a90a6f982024-11-28WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
unii: F05Q2T2JA0
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLC26f8b63c-6dad-8fac-e063-6394a90a54352024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with LaxativeDOCUSATE SODIUM AND SENNOSIDESBryant Ranch Prepacke24638d3-7738-4185-8ce9-1845d8594cc62024-11-04WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
unii: F05Q2T2JA0
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: OJ245FE5EU
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
unii: F05Q2T2JA0
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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