Amlodipine and Olmesartan Medoxomil

Product NDC
57664-773
11-digit product format
576640773
Labeler code
57664
Product ID
57664-773_439ecdf0-8908-4f16-a2e9-c13e17a51e43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA022100
Marketing category
NDA
Marketing start
2016-10-26
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
10 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-773-83EA - Each57664-773a8f401ba-dec2-4b73-a0be-8e02dc5f7af412016-11-08
57664-773-99EA - Each57664-773bf52af6e-5349-4d94-b916-b72201bc69f212016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-773-835766407738330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-773-83) 2016-10-260000-00-00NoNoCurrent
57664-773-995766407739990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-773-99) 2016-10-260000-00-00NoNoCurrent