Amlodipine and Olmesartan Medoxomil

Product NDC
13668-313
11-digit product format
136680313
Labeler code
13668
Product ID
13668-313_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
5 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
13668-313-30EA - Each13668-313066923e1-5ae2-40e3-ac4c-7ba58745fb8e12017-04-05
13668-313-90EA - Each13668-313bd2a4a94-6ec7-4591-8c1b-5f72a7af657e12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-313-0513668031305500 TABLET in 1 BOTTLE (13668-313-05) 500 tablet2016-11-250000-00-00NoNoCurrent
13668-313-10136680313101000 TABLET in 1 BOTTLE (13668-313-10) 1000 tablet2016-11-250000-00-00NoNoCurrent
13668-313-301366803133030 TABLET in 1 BOTTLE (13668-313-30) 30 tablet2016-11-250000-00-00NoNoCurrent
13668-313-7413668031374100 TABLET in 1 BOTTLE (13668-313-74) 100 tablet2016-11-250000-00-00NoNoCurrent
13668-313-901366803139090 TABLET in 1 BOTTLE (13668-313-90) 90 tablet2016-11-250000-00-00NoNoCurrent