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Amlodipine and Valsartan

These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS. AMLODIPINE AND VALSARTAN tablets, for oral useInitial U.S. Approval: 2007

Approved
Approval ID

55a1d22e-04ad-4475-9b05-0d534e289160

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 21, 2023

Manufacturers
FDA

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

DUNS: 780779901

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

amlodipine and valsartan

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-846
Application NumberANDA090011
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine and valsartan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2023
FDA Product Classification

INGREDIENTS (6)

VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMLODIPINEActive
Quantity: 5 mg in 1 1
Code: 1J444QC288
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT

amlodipine and valsartan

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-847
Application NumberANDA090011
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine and valsartan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2023
FDA Product Classification

INGREDIENTS (6)

AMLODIPINEActive
Quantity: 10 mg in 1 1
Code: 1J444QC288
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
VALSARTANActive
Quantity: 320 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB

amlodipine and valsartan

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-844
Application NumberANDA090011
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine and valsartan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2023
FDA Product Classification

INGREDIENTS (6)

VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMLODIPINEActive
Quantity: 5 mg in 1 1
Code: 1J444QC288
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

amlodipine and valsartan

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-845
Application NumberANDA090011
Product Classification
M
Marketing Category
C73584
G
Generic Name
amlodipine and valsartan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2023
FDA Product Classification

INGREDIENTS (6)

VALSARTANActive
Quantity: 160 mg in 1 1
Code: 80M03YXJ7I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
AMLODIPINEActive
Quantity: 10 mg in 1 1
Code: 1J444QC288
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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Amlodipine and Valsartan - FDA Drug Approval Details