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#

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 12 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMMylan Pharmaceuticals Inc.13930c94-d83a-414f-be35-b1fef35f738d2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
unii: F05Q2T2JA0
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMSafecor Health, LLCefe4bf81-fb99-4755-aa23-4f8df5973be82025-01-08WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.02840ea6-e4a0-96a0-e063-6394a90a19ae2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGNCS HealthCare of KY, LLC dba Vangard Labsc049ef78-cc16-4209-b553-60cead5c9a802025-01-03WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed32025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197322
unii: YU55MQ3IZY
Laxative Docusate Sodium with SennaDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCcf9075d8-e20e-419a-b996-9b12f49f05f22025-01-01WarningsExact identifier
unii: F05Q2T2JA0
Vegetable Laxative and Stool SoftnerDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCe84d693d-0041-4c11-8f6a-b5c332f79af92025-01-01WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb39e2bc8-b68f-0f4e-e053-2995a90a00fd2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb4cd647f-1ba3-334e-e053-2995a90af3522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCf667458d-ddda-4e9e-e053-2995a90adb5a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 308048
unii: YU55MQ3IZY
LaxacinDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx Pharmacy of Tennessee, LLCfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2024-12-31WarningsExact identifier
unii: F05Q2T2JA0
AlprazolamALPRAZOLAMAmerican Health Packagingea95d182-453b-4c43-8402-d65c488d55f22024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
rxcui: 308048
unii: YU55MQ3IZY
DOCUSATE SODIUMDOCUSATE SODIUMA-S Medication Solutions946abcdb-96bd-43e6-992a-bb97679c00f02024-12-30WarningsExact identifier
unii: F05Q2T2JA0
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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