FDA.reportPublic FDA data

GEMFIBROZIL

Product NDC
68071-2387
11-digit product format
680712387
Labeler code
68071
Product ID
68071-2387_4c5002dc-5149-b9f8-e063-6394a90ac88a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214603
Marketing category
ANDA
Marketing start
2021-01-20
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GEMFIBROZIL
Listing expiration
2027-12-31

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
68071-2387-32023-01-30C16284748780-1f386c649-b513-0266-e053-dadaa90a7c1aGemfibrozil Tablets, USP
68071-2387-62023-01-30C16284748780-1f386c649-b513-0266-e053-dadaa90a7c1aGemfibrozil Tablets, USP
68071-2387-82023-01-30C16284748780-1f386c649-b513-0266-e053-dadaa90a7c1aGemfibrozil Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2387-3GEMFIBROZIL30 in 1 BOTTLETABLET302
68071-2387-6GEMFIBROZIL60 in 1 BOTTLETABLET602
68071-2387-8GEMFIBROZIL180 in 1 BOTTLETABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2387GEMFIBROZIL TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 3 package rows20210414_bfddc3bd-c2dc-449e-e053-2a95a90a8adc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNbfddc3bd-c2dc-449e-e053-2a95a90a8adc2
310459gemfibrozil 600 MG Oral TabletSCDbfddc3bd-c2dc-449e-e053-2a95a90a8adc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2387-36807123870330 TABLET in 1 BOTTLE (68071-2387-3) 30 tablet2021-04-130000-00-00NoNoCurrent
68071-2387-66807123870660 TABLET in 1 BOTTLE (68071-2387-6) 60 tablet2021-04-130000-00-00NoNoCurrent
68071-2387-868071238708180 TABLET in 1 BOTTLE (68071-2387-8) 180 tablet2021-04-130000-00-00NoNoCurrent