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Alendronate Sodium

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

Approved
Approval ID

81589178-10c9-4806-91eb-54e638d35b8d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 24, 2023

Manufacturers
FDA

ANI Pharmaceuticals, Inc.

DUNS: 145588013

Products 1

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 Code70954-264
Application NumberANDA214512
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification

INGREDIENTS (7)

PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 70 mg in 75 mL
Code: 2UY4M2U3RA
Classification: ACTIM
SACCHARIN SODIUM MONOHYDRATEInactive
Code: A9CO00M9HV
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Alendronate Sodium - FDA Drug Approval Details