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) tablets , for oral use Initial U.S. Approval: 200 7
Approved
Approval ID
f48911e0-705f-11dc-afc9-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2022
Manufacturers
FDA
Daiichi Sankyo Inc.
DUNS: 068605067
Products 4
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 Code65597-110
Application NumberNDA022100
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (10)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-111
Application NumberNDA022100
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (13)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-113
Application NumberNDA022100
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (12)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-112
Application NumberNDA022100
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (11)
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT