FDA.reportPublic FDA data

Gemfibrozil

Product NDC
75834-131
11-digit product format
758340131
Labeler code
75834
Product ID
75834-131_46c22ec0-5ec6-472c-a8cf-b89c27dc6448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA203266
Marketing category
ANDA
Marketing start
2017-02-15
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gemfibrozil
Listing expiration
2026-12-31

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
75834-131-052022-02-16C16284748780-1d6a99b39-51ef-a426-e053-dadaa90af4c2GEMFIBROZIL TABLETS USP, 600 mg - gemfibrozil tablets
75834-131-182022-02-16C16284748780-1d6a99b39-51ef-a426-e053-dadaa90af4c2GEMFIBROZIL TABLETS USP, 600 mg - gemfibrozil tablets
75834-131-602022-02-16C16284748780-1d6a99b39-51ef-a426-e053-dadaa90af4c2GEMFIBROZIL TABLETS USP, 600 mg - gemfibrozil tablets
75834-131-052022-01-28C16284748780-1d6a99b39-51ef-a426-e053-dadaa90af4c2GEMFIBROZIL TABLETS USP, 600 mg - gemfibrozil tablets
75834-131-182022-01-28C16284748780-1d6a99b39-51ef-a426-e053-dadaa90af4c2GEMFIBROZIL TABLETS USP, 600 mg - gemfibrozil tablets
75834-131-602022-01-28C16284748780-1d6a99b39-51ef-a426-e053-dadaa90af4c2GEMFIBROZIL TABLETS USP, 600 mg - gemfibrozil tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-131-05Gemfibrozil500 in 1 BOTTLETABLET5003
75834-131-18Gemfibrozil180 in 1 BOTTLETABLET1803
75834-131-60Gemfibrozil60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-131-05EA - Each75834-13131ff2959-b134-4878-bdbd-513369c827d412017-03-06
75834-131-18EA - Each75834-1316abe0d2b-f82d-4826-b195-1f93dbf2f91012017-03-06
75834-131-60EA - Each75834-1310c6e3163-fc19-445d-8a49-62648e21b01e12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-131GEMFIBROZIL TABLET [NIVAGEN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20220217_a086fc16-e6f3-47fd-b577-7c611e735834.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNfe91d458-1877-4c2e-aa15-efd802e6741f102
310459gemfibrozil 600 MG Oral TabletSCDfe91d458-1877-4c2e-aa15-efd802e6741f102
310459gemfibrozil 600 MG Oral TabletPSNa086fc16-e6f3-47fd-b577-7c611e7358343
310459gemfibrozil 600 MG Oral TabletSCDa086fc16-e6f3-47fd-b577-7c611e7358343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-131-0575834013105500 TABLET in 1 BOTTLE (75834-131-05) 500 tablet2017-02-150000-00-00NoNoCurrent
75834-131-1875834013118180 TABLET in 1 BOTTLE (75834-131-18) 180 tablet2017-02-150000-00-00NoNoCurrent
75834-131-607583401316060 TABLET in 1 BOTTLE (75834-131-60) 60 tablet2017-02-150000-00-00NoNoCurrent