Gemfibrozil

Product NDC
50090-6939
11-digit product format
500906939
Labeler code
50090
Product ID
50090-6939_cd560cd9-4e1d-4641-8c3b-d994ed0dcafc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079072
Marketing category
ANDA
Marketing start
2010-12-20
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
Q8X02027X3GEMFIBROZIL25812-30-0GEMFIBROZIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6939-05009069390090 TABLET in 1 BOTTLE (50090-6939-0) 90 tablet2023-12-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx OnlyA-S Medication Solutions2023-12-18Human Prescription Drug Label1