FDA.reportPublic FDA data

NDC 0591-0454 - Gemfibrozil

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
0591-0454
Package NDCs from labels
0591-0454-60, 0591-0454-05
Manufacturer
Watson Laboratories, Inc.
Effective date
2007-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
70011405 FPO Gemfibrozil Tablets USP Revised: July 2004 Rx onlyWatson Laboratories, Inc.2007-01-01HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0454-05Gemfibrozil500 in 1 BOTTLETABLET5001
0591-0454-60Gemfibrozil60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0454GEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]12 package rows20070111_A1DA5A84-7529-4F62-867F-808A6CAB40B8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GemfibrozilACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
GemfibrozilACTIVE MOIETYQ8X02027X3GEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
calcium stearateINACTIVE INGREDIENT776XM7047LGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
colloidal silicon dioxideINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
FD & C red #40 aluminum lakeINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
FD & C red #6 aluminum lakeINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
polyethylene glycolINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
polysorbate 80INACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
pregelatinized starchINACTIVE INGREDIENTGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL (GEMFIBROZIL) TABLET [WATSON LABORATORIES, INC.]1

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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GemfibrozilGEMFIBROZILCipla USA Inc.05bfbcdc-03ab-4fba-9582-980602410ef92021-06-18Warnings, Adverse reactionsExact identifier
rxcui: 310459
GemfibrozilGEMFIBROZILAphena Pharma Solutions - Tennessee, LLCeb1a2edf-587e-42c5-a98b-58646bc3f9482019-01-08Warnings, Adverse reactionsExact identifier
rxcui: 310459
GemfibrozilGEMFIBROZILAphena Pharma Solutions - Tennessee, LLC30a0d14a-f7a7-4ecf-99cd-6b907c8e0fe82018-08-22Warnings, Adverse reactionsExact identifier
rxcui: 310459
A1DA5A84-7529-4F62-867F-808A6CAB40B8A1DA5A84-7529-4F62-867F-808A6CAB40B82007-01-01Warnings, Adverse reactionsExact identifier
spl id: A1DA5A84-7529-4F62-867F-808A6CAB40B8
spl set id: A1DA5A84-7529-4F62-867F-808A6CAB40B8

Reported adverse events (FAERS/openFDA)#

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