Amlodipine and Olmesartan Medoxomil

Product NDC
65862-857
11-digit product format
658620857
Labeler code
65862
Product ID
65862-857_4879a01c-0ba7-4d27-9847-f22e8546fa8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206906
Marketing category
ANDA
Marketing start
2017-05-15
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
10; 40 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
864V2Q084HAMLODIPINE BESYLATE111470-99-6AMLODIPINE BESYLATE
6M97XTV3HDOLMESARTAN MEDOXOMIL144689-63-4OLMESARTAN MEDOXOMIL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65862-857-306586208573030 TABLET, FILM COATED in 1 BOTTLE (65862-857-30) 2017-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine and Olmesartan MedoxomilAurobindo Pharma Limited2024-04-15Human Prescription Drug Label7