Gemfibrozil

Product NDC
63629-1390
11-digit product format
636291390
Labeler code
63629
Product ID
63629-1390_ea9fdf28-6b36-4d0c-95b3-05e3a2e188cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075034
Marketing category
ANDA
Marketing start
1998-10-01
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1390-1EA - Each63629-1390460a07f6-1504-4b16-9c1d-1c0d8f2da0dd12013-02-13
63629-1390-2EA - Each63629-1390efcaa819-b8c5-434d-8cd8-ba3a66cd77d612013-02-13
63629-1390-3EA - Each63629-139029362a1b-e570-475f-9a3d-52049cb0e29f12013-02-13