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
a855ce60-6918-490a-9158-3be5a0ef76b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2019
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-394
Application NumberANDA209600
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2019
FDA Product Classification
INGREDIENTS (13)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-393
Application NumberANDA209600
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2019
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-392
Application NumberANDA209600
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2019
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
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
amlodipine besylate and olmesartan medoxomil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-395
Application NumberANDA209600
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine besylate and olmesartan medoxomil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2019
FDA Product Classification
INGREDIENTS (13)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
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
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB