Amlodipine and olmesartan medoxomil

Product NDC
70771-1189
11-digit product format
707711189
Labeler code
70771
Product ID
70771-1189_adc1edc9-9897-4ba0-a14d-08c8d29f9369
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207771
Marketing category
ANDA
Marketing start
2018-01-04
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
10 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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
70771-1189-0707711189001000 TABLET, FILM COATED in 1 BOTTLE (70771-1189-0) 2018-01-040000-00-00NoNoCurrent
70771-1189-170771118901100 TABLET, FILM COATED in 1 BOTTLE (70771-1189-1) 2018-01-040000-00-00NoNoCurrent
70771-1189-37077111890330 TABLET, FILM COATED in 1 BOTTLE (70771-1189-3) 2018-01-040000-00-00NoNoCurrent
70771-1189-47077111890410 BLISTER PACK in 1 CARTON (70771-1189-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1189-2) 10 blister pack2018-01-040000-00-00NoNoCurrent
70771-1189-570771118905500 TABLET, FILM COATED in 1 BOTTLE (70771-1189-5) 2018-01-040000-00-00NoNoCurrent
70771-1189-97077111890990 TABLET, FILM COATED in 1 BOTTLE (70771-1189-9) 2018-01-040000-00-00NoNoCurrent