Amlodipine and Olmesartan Medoxomil

Product NDC
63629-8218
11-digit product format
636298218
Labeler code
63629
Product ID
63629-8218_be70cfef-9e3e-448d-ac5c-641d10335d00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206906
Marketing category
ANDA
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; 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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8218-16362982180130 TABLET, FILM COATED in 1 BOTTLE (63629-8218-1) 2019-08-150000-00-00NoNoCurrent