Irbesartan

Product NDC
70518-1329
11-digit product format
705181329
Labeler code
70518
Product ID
70518-1329_9243087f-1457-83f7-e053-2a95a90ae53f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202254
Marketing category
ANDA
Marketing start
2018-07-30
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
300 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record