Azor
These highlights do not include all the information needed to use Azor safely and effectively. See full prescribing information for Azor. Azor (amlodipine and olmesartan medoxomil) tablet, film coated for oral use Initial U.S. Approval: 2007
Approved
Approval ID
d6f37813-40bb-4fe8-99e2-ad2339b8e04a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6036
Application NumberNDA022100
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2012
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6250
Application NumberNDA022100
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2012
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT