Amlodipine and Olmesartan Medoxomil

Product NDC
13668-311
11-digit product format
136680311
Labeler code
13668
Product ID
13668-311_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
13668-311-30EA - Each13668-3119d02312c-bc4a-45e6-975a-ece2932d8d8c12017-04-05
13668-311-90EA - Each13668-311ff8c6cc5-d8d0-4953-aa07-6d23f936fa2612017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-311-0513668031105500 TABLET in 1 BOTTLE (13668-311-05) 500 tablet2016-11-250000-00-00NoNoCurrent
13668-311-10136680311101000 TABLET in 1 BOTTLE (13668-311-10) 1000 tablet2016-11-250000-00-00NoNoCurrent
13668-311-301366803113030 TABLET in 1 BOTTLE (13668-311-30) 30 tablet2016-11-250000-00-00NoNoCurrent
13668-311-7413668031174100 TABLET in 1 BOTTLE (13668-311-74) 100 tablet2016-11-250000-00-00NoNoCurrent
13668-311-901366803119090 TABLET in 1 BOTTLE (13668-311-90) 90 tablet2016-11-250000-00-00NoNoCurrent