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Alendronate Sodium

These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively.  See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995

Approved
Approval ID

c23fb7fe-c6b9-4f77-bde7-992222b589d3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 2, 2021

Manufacturers
FDA

Amneal Pharmaceuticals of New York LLC

DUNS: 123797875

Products 5

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

Alendronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-1679
Application NumberANDA075710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (4)

ALENDRONATE SODIUMActive
Quantity: 35 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Alendronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-1681
Application NumberANDA075710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (4)

ALENDRONATE SODIUMActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT

Alendronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-1676
Application NumberANDA075710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (4)

ALENDRONATE SODIUMActive
Quantity: 5 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

Alendronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-1678
Application NumberANDA075710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (4)

ALENDRONATE SODIUMActive
Quantity: 10 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Alendronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-1680
Application NumberANDA075710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (4)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 40 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Alendronate Sodium - FDA Drug Approval Details