FDA.reportPublic FDA data

Gemfibrozil

Product NDC
50090-7233
11-digit product format
500907233
Labeler code
50090
Product ID
50090-7233_f066ee58-5917-4c32-886d-40d1f78c6537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202726
Marketing category
ANDA
Marketing start
2015-09-16
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
50090-7233-0Gemfibrozil60 in 1 BOTTLETABLET, FILM COATED601
50090-7233-2Gemfibrozil90 in 1 BOTTLETABLET, FILM COATED901
50090-7233-3Gemfibrozil30 in 1 BOTTLETABLET, FILM COATED301
50090-7233-4Gemfibrozil180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7233-0EA - Each50090-723310c1842e-dea9-4c83-8bbd-f345515dfa4a12024-10-04
50090-7233-2EA - Each50090-723380b271ae-3a5a-4ce5-96ab-94357c59c3e412024-10-04
50090-7233-3EA - Each50090-723398922396-1c24-437d-8dc9-a354a1c9d04012024-10-04
50090-7233-4EA - Each50090-72335405ba30-c745-460f-8467-57773fe3724512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7233GEMFIBROZIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20240830_efecc680-f626-46bf-bc2b-3b5a72ba0267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNefecc680-f626-46bf-bc2b-3b5a72ba02671
310459gemfibrozil 600 MG Oral TabletSCDefecc680-f626-46bf-bc2b-3b5a72ba02671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7233-05009072330060 TABLET, FILM COATED in 1 BOTTLE (50090-7233-0) 2024-08-26NoNoHistorical
50090-7233-25009072330290 TABLET, FILM COATED in 1 BOTTLE (50090-7233-2) 2024-08-26NoNoHistorical
50090-7233-35009072330330 TABLET, FILM COATED in 1 BOTTLE (50090-7233-3) 2024-08-26NoNoHistorical
50090-7233-450090723304180 TABLET, FILM COATED in 1 BOTTLE (50090-7233-4) 2024-08-26NoNoHistorical