alendronate sodium

Generic: alendronate sodium

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1681
Product ID 0115-1681_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075710
Listing Expiration 2026-12-31
Marketing Start 2008-02-06

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151681
Hyphenated Format 0115-1681

Supplemental Identifiers

RxCUI
904396 904405 904419 904425 904431
UPC
0301151681347 0301151679344 0301151676084 0301151678088 0301151680081
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 ANDA075710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (0115-1681-26) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)
  • 4 BLISTER PACK in 1 CARTON (0115-1681-34) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)
source: ndc

Packages (2)

0115-1681-26 12 BLISTER PACK in 1 CARTON (0115-1681-26) / 1 TABLET in 1 BLISTER PACK (0115-1681-30) 0115-1681-34 4 BLISTER PACK in 1 CARTON (0115-1681-34) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)

Ingredients (1)

alendronate sodium (70 mg/1)

Linked Drug Pages (1)

Alendronate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1", "openfda": {"upc": ["0301151681347", "0301151679344", "0301151676084", "0301151678088", "0301151680081"], "unii": ["2UY4M2U3RA"], "rxcui": ["904396", "904405", "904419", "904425", "904431"], "spl_set_id": ["c23fb7fe-c6b9-4f77-bde7-992222b589d3"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0115-1681-26)  / 1 TABLET in 1 BLISTER PACK (0115-1681-30)", "package_ndc": "0115-1681-26", "marketing_start_date": "20080206"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (0115-1681-34)  / 1 TABLET in 1 BLISTER PACK (0115-1681-30)", "package_ndc": "0115-1681-34", "marketing_start_date": "20080206"}], "brand_name": "Alendronate Sodium", "product_id": "0115-1681_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "0115-1681", "generic_name": "Alendronate Sodium", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alendronate Sodium", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/1"}], "application_number": "ANDA075710", "marketing_category": "ANDA", "marketing_start_date": "20080206", "listing_expiration_date": "20261231"}