Gemfibrozil

Product NDC
63187-772
11-digit product format
631870772
Labeler code
63187
Product ID
63187-772_e7d02874-58bd-44fb-afdf-41b8f82a93e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077836
Marketing category
ANDA
Marketing start
2016-07-08
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
63187-772-306318707723030 TABLET in 1 BOTTLE (63187-772-30) 30 tablet2016-11-01NoNoHistorical
63187-772-606318707726060 TABLET in 1 BOTTLE (63187-772-60) 60 tablet2016-11-01NoNoHistorical
63187-772-7263187077272120 TABLET in 1 BOTTLE (63187-772-72) 120 tablet2016-11-01NoNoHistorical
63187-772-7863187077278180 TABLET in 1 BOTTLE (63187-772-78) 180 tablet2016-11-01NoNoHistorical
63187-772-906318707729090 TABLET in 1 BOTTLE (63187-772-90) 90 tablet2016-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Gemfibrozil Tablets, 600 mgProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL5