alendronate sodium

Generic: alendronate sodium

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/75mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-264
Product ID 70954-264_844cce5a-3714-4394-be02-a25a6255330a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214512
Listing Expiration 2027-12-31
Marketing Start 2023-05-24

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954264
Hyphenated Format 70954-264

Supplemental Identifiers

RxCUI
904447
UPC
0370954264101
UNII
2UY4M2U3RA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alendronate sodium (source: ndc)
Generic Name alendronate sodium (source: ndc)
Application Number ANDA214512 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/75mL
source: ndc
Packaging
  • 4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-264-10 4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE

Ingredients (1)

alendronate sodium (70 mg/75mL)

Linked Drug Pages (1)

Alendronate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "844cce5a-3714-4394-be02-a25a6255330a", "openfda": {"upc": ["0370954264101"], "unii": ["2UY4M2U3RA"], "rxcui": ["904447"], "spl_set_id": ["81589178-10c9-4806-91eb-54e638d35b8d"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE in 1 CARTON (70954-264-10)  / 75 mL in 1 BOTTLE", "package_ndc": "70954-264-10", "marketing_start_date": "20230524"}], "brand_name": "Alendronate Sodium", "product_id": "70954-264_844cce5a-3714-4394-be02-a25a6255330a", "dosage_form": "SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "70954-264", "generic_name": "Alendronate Sodium", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alendronate Sodium", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/75mL"}], "application_number": "ANDA214512", "marketing_category": "ANDA", "marketing_start_date": "20230524", "listing_expiration_date": "20271231"}