Amlodipine besylate and Olmesartan medoxomil
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 use Initial U.S. Approval: 2007
Approved
Approval ID
69fa6293-b10a-4473-ab9b-1bd53f099bdd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-084
Application NumberANDA207216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate and Olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (12)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Amlodipine besylate and Olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-085
Application NumberANDA207216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate and Olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (14)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Amlodipine besylate and Olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-083
Application NumberANDA207216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate and Olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Amlodipine besylate and Olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-086
Application NumberANDA207216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine besylate and Olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (14)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT