FDA.reportPublic FDA data

Gemfibrozil

Product NDC
50268-350
11-digit product format
502680350
Labeler code
50268
Product ID
50268-350_42522f26-564b-a89e-e063-6394a90a3ffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA077836
Marketing category
ANDA
Marketing start
2014-07-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-350-11Gemfibrozil1 in 1 BLISTER PACKTABLET111
50268-350-15Gemfibrozil50 in 1 BOXTABLET5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-350-11EA - Each50268-350aebc158a-a5c7-4257-8213-5f1b8e13f08612014-12-01
50268-350-15EA - Each50268-3500471f769-fa78-416c-8fef-3fca4fef06c512014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET [AVPAK]3
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET [AVPAK]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET [AVPAK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET [AVPAK]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GEMFIBROZIL TABLET [AVPAK]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82GEMFIBROZIL TABLET [AVPAK]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6GEMFIBROZIL TABLET [AVPAK]3
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8GEMFIBROZIL TABLET [AVPAK]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGEMFIBROZIL TABLET [AVPAK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET [AVPAK]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET [AVPAK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-350GEMFIBROZIL TABLET [AVPAK]10Current NDC, Legacy NDC, 2 package rows20250112_3ebb5947-1fe5-9740-6a4b-1f8b577b2711.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN3ebb5947-1fe5-9740-6a4b-1f8b577b271111
310459gemfibrozil 600 MG Oral TabletSCD3ebb5947-1fe5-9740-6a4b-1f8b577b271111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-350-11502680350111 in 1 BLISTER PACKHistorical
50268-350-155026803501550 BLISTER PACK in 1 BOX (50268-350-15) / 1 TABLET in 1 BLISTER PACK (50268-350-11) 50 blister pack2014-07-100000-00-00NoNoCurrent