Irbesartan

Product NDC
70771-1160
11-digit product format
707711160
Labeler code
70771
Product ID
70771-1160_120947cf-df25-4bbc-93bc-1ea48be2bdb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA079213
Marketing category
ANDA
Marketing start
2017-12-08
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
150 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1160-0707711160001000 TABLET in 1 BOTTLE (70771-1160-0) 1000 tablet2017-12-080000-00-00NoNoCurrent
70771-1160-37077111600330 TABLET in 1 BOTTLE (70771-1160-3) 30 tablet2017-12-080000-00-00NoNoCurrent
70771-1160-47077111600410 BLISTER PACK in 1 CARTON (70771-1160-4) > 10 TABLET in 1 BLISTER PACK (70771-1160-2) 10 blister pack2017-12-080000-00-00NoNoCurrent
70771-1160-570771116005500 TABLET in 1 BOTTLE (70771-1160-5) 500 tablet2017-12-080000-00-00NoNoCurrent
70771-1160-97077111600990 TABLET in 1 BOTTLE (70771-1160-9) 90 tablet2017-12-080000-00-00NoNoCurrent