alendronate sodium

Generic: alendronate sodium

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

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 35 mg/1

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-681
Product ID 76282-681_2012c7a8-8aa7-4c18-a8c3-fe74d74ac873
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076768
Listing Expiration 2026-12-31
Marketing Start 2021-02-02

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282681
Hyphenated Format 76282-681

Supplemental Identifiers

RxCUI
904396 904431
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 ANDA076768 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (76282-681-46) / 4 TABLET in 1 BLISTER PACK (76282-681-45)
source: ndc

Packages (1)

76282-681-46 3 BLISTER PACK in 1 CARTON (76282-681-46) / 4 TABLET in 1 BLISTER PACK (76282-681-45)

Ingredients (1)

alendronate sodium (35 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": "2012c7a8-8aa7-4c18-a8c3-fe74d74ac873", "openfda": {"unii": ["2UY4M2U3RA"], "rxcui": ["904396", "904431"], "spl_set_id": ["91a0f73a-d8cd-4197-b431-40707a2150b9"], "manufacturer_name": ["EXELAN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (76282-681-46)  / 4 TABLET in 1 BLISTER PACK (76282-681-45)", "package_ndc": "76282-681-46", "marketing_start_date": "20210202"}], "brand_name": "ALENDRONATE SODIUM", "product_id": "76282-681_2012c7a8-8aa7-4c18-a8c3-fe74d74ac873", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "76282-681", "generic_name": "Alendronate sodium", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALENDRONATE SODIUM", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA076768", "marketing_category": "ANDA", "marketing_start_date": "20210202", "listing_expiration_date": "20261231"}