Telmisartan and Amlodipine
These highlights do not include all the information needed to use TELMISARTAN AND AMLODIPINE TABLETS safely and effectively. See full prescribing information for TELMISARTAN AND AMLODIPINE TABLETS. TELMISARTAN and AMLODIPINE tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
15b438b4-4874-43f4-a50a-4e6f3e5530ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-185
Application NumberANDA205234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (13)
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-187
Application NumberANDA205234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (13)
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-186
Application NumberANDA205234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (13)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-184
Application NumberANDA205234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (13)
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT