FDA.reportPublic FDA data

GEMFIBROZIL

Product NDC
68788-7964
11-digit product format
687887964
Labeler code
68788
Product ID
68788-7964_f8ae4088-7e33-4a6c-943c-20dee3256974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA214603
Marketing category
ANDA
Marketing start
2021-07-20
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7964-3GEMFIBROZIL30 in 1 BOTTLETABLET306
68788-7964-6GEMFIBROZIL60 in 1 BOTTLETABLET606
68788-7964-9GEMFIBROZIL90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7964-3EA - Each68788-7964938cbe6d-ff57-4a71-b7e8-69ccb1d30afd12021-08-05
68788-7964-6EA - Each68788-79645277e16c-04a1-47be-894e-72a20fb4ec8012021-08-05
68788-7964-9EA - Each68788-7964e93ae892-c50b-4646-a224-11289e27e5f012021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7964GEMFIBROZIL TABLET [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240509_2f5738ac-1c9c-4f3a-8c7d-6039d768831e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN2f5738ac-1c9c-4f3a-8c7d-6039d768831e6
310459gemfibrozil 600 MG Oral TabletSCD2f5738ac-1c9c-4f3a-8c7d-6039d768831e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7964-36878879640330 TABLET in 1 BOTTLE (68788-7964-3) 30 tablet2021-07-200000-00-00NoNoCurrent
68788-7964-66878879640660 TABLET in 1 BOTTLE (68788-7964-6) 60 tablet2021-07-200000-00-00NoNoCurrent
68788-7964-96878879640990 TABLET in 1 BOTTLE (68788-7964-9) 90 tablet2021-07-200000-00-00NoNoCurrent