FDA.reportPublic FDA data

Gemfibrozil

Product NDC
71335-0971
11-digit product format
713350971
Labeler code
71335
Product ID
71335-0971_52a2582f-0237-4d41-9496-f222ed522e1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079072
Marketing category
ANDA
Marketing start
2010-12-20
Marketing end
2026-06-30
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gemfibrozil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEMFIBROZIL600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ8X02027X3
Rxcui310459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0971-12024-09-11C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-22024-09-11C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-32024-09-11C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-42024-09-11C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-52024-09-11C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-12024-01-30C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-22024-01-30C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-32024-01-30C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-42024-01-30C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only
71335-0971-52024-01-30C16284748780-11030e365-14cd-111a-e063-dadaa90a10e2Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0971-1Gemfibrozil60 in 1 BOTTLETABLET605
71335-0971-2Gemfibrozil30 in 1 BOTTLETABLET305
71335-0971-3Gemfibrozil100 in 1 BOTTLETABLET1005
71335-0971-4Gemfibrozil90 in 1 BOTTLETABLET905
71335-0971-5Gemfibrozil180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0971GEMFIBROZIL TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20240913_325afd72-9176-4a08-8383-58cecb35196d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN325afd72-9176-4a08-8383-58cecb35196d5
310459gemfibrozil 600 MG Oral TabletSCD325afd72-9176-4a08-8383-58cecb35196d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0971-17133509710160 TABLET in 1 BOTTLE (71335-0971-1) 60 tablet2018-10-222026-06-30NoNoCurrent
71335-0971-27133509710230 TABLET in 1 BOTTLE (71335-0971-2) 30 tablet2018-11-092026-06-30NoNoCurrent
71335-0971-371335097103100 TABLET in 1 BOTTLE (71335-0971-3) 100 tablet2024-09-052026-06-30NoNoCurrent
71335-0971-47133509710490 TABLET in 1 BOTTLE (71335-0971-4) 90 tablet2024-09-052026-06-30NoNoCurrent
71335-0971-571335097105180 TABLET in 1 BOTTLE (71335-0971-5) 180 tablet2024-09-052026-06-30NoNoCurrent