alendronate

Generic: alendronate sodium tablet

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

Drug Facts

Product Profile

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

alendronate sodium 35 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-718
Product ID 10135-718_3e74abef-2742-2bbe-e063-6394a90a12cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090258
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135718
Hyphenated Format 10135-718

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 (source: ndc)
Generic Name alendronate sodium tablet (source: ndc)
Application Number ANDA090258 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

10135-718-12 3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACK 10135-718-44 1 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACK

Ingredients (1)

alendronate sodium (35 mg/1)

Linked Drug Pages (1)

Alendronate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e74abef-2742-2bbe-e063-6394a90a12cd", "openfda": {"unii": ["2UY4M2U3RA"], "rxcui": ["904396", "904431"], "spl_set_id": ["b63421af-ec03-1de7-e053-2a95a90abec6"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (10135-718-12)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "10135-718-12", "marketing_start_date": "20201201"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (10135-718-44)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "10135-718-44", "marketing_start_date": "20201201"}], "brand_name": "Alendronate", "product_id": "10135-718_3e74abef-2742-2bbe-e063-6394a90a12cd", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "10135-718", "generic_name": "Alendronate sodium tablet", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alendronate", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA090258", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}