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 useInitial U.S. Approval: 2009
Approved
Approval ID
a97fefa6-99e6-4eb7-9393-ab2252a2c7d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-196
Application NumberANDA201586
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (11)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-199
Application NumberANDA201586
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (11)
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-197
Application NumberANDA201586
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (11)
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Telmisartan and Amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-198
Application NumberANDA201586
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan and Amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (11)
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT