Gemfibrozil

Product NDC
68071-2422
11-digit product format
680712422
Labeler code
68071
Product ID
68071-2422_c3542eba-3c1e-57ba-e053-2995a90a517b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA079072
Marketing category
ANDA
Marketing start
2010-12-20
Marketing end
0000-00-00
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
Q8X02027X3GEMFIBROZIL25812-30-0GEMFIBROZIL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2422-868071242208180 TABLET in 1 BOTTLE (68071-2422-8) 180 tablet2021-05-270000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx OnlyNuCare Pharmaceuticals,Inc.2021-05-27HUMAN PRESCRIPTION DRUG LABEL24