Amlodipine and Olmesartan Medoxomil

Product NDC
13668-312
11-digit product format
136680312
Labeler code
13668
Product ID
13668-312_dc8d740a-a8a3-1d06-e053-2a95a90aa6c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA202933
Marketing category
ANDA
Marketing start
2016-11-25
Marketing end
0000-00-00
Substance
AMLODIPINE; 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], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-312-30EA - Each13668-31208b9ccea-1a51-466b-8aca-3bd164fa926612017-04-05
13668-312-90EA - Each13668-312de0a24ca-3c77-420c-9c8d-db08abbaf5cc12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-312-0513668031205500 TABLET in 1 BOTTLE (13668-312-05) 500 tablet2016-11-250000-00-00NoNoCurrent
13668-312-10136680312101000 TABLET in 1 BOTTLE (13668-312-10) 1000 tablet2016-11-250000-00-00NoNoCurrent
13668-312-301366803123030 TABLET in 1 BOTTLE (13668-312-30) 30 tablet2016-11-250000-00-00NoNoCurrent
13668-312-7413668031274100 TABLET in 1 BOTTLE (13668-312-74) 100 tablet2016-11-250000-00-00NoNoCurrent
13668-312-901366803129090 TABLET in 1 BOTTLE (13668-312-90) 90 tablet2016-11-250000-00-00NoNoCurrent