Amlodipine and Olmesartan Medoxomil

Basic Information

Product Name

FDA Product Code

50228-365

Regulatory Information

NDC Product Code

50228-365

Application Number

ANDA209010

Marketing Category

C73584

Effective Date

December 10, 2018

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE and OLMESARTAN MEDOXOMIL tablets, for oral useInitial U.S. Approval: 2007

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

AMLODIPINE BESYLATE

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

OLMESARTAN MEDOXOMIL

Quantity: 20 mg in 1 1

Code: 6M97XTV3HD

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

AMLODIPINE

Code: 1J444QC288

OLMESARTAN

Code: 8W1IQP3U10

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

CROSCARMELLOSE SODIUM

SILICON DIOXIDE

POLYVINYL ALCOHOL, UNSPECIFIED

POLYETHYLENE GLYCOL 3350

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL 8000

TALC

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

Active Moieties

AMLODIPINE

OLMESARTAN