fosamax

Generic: alendronate sodium

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosamax
Generic Name alendronate sodium
Labeler organon llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-135
Product ID 78206-135_9cc10d27-3960-41a0-9736-8fe902c6984f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020560
Listing Expiration 2027-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206135
Hyphenated Format 78206-135

Supplemental Identifiers

RxCUI
904431 904433
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 fosamax (source: ndc)
Generic Name alendronate sodium (source: ndc)
Application Number NDA020560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BLISTER PACK (78206-135-01)
source: ndc

Packages (1)

78206-135-01 4 TABLET in 1 BLISTER PACK (78206-135-01)

Ingredients (1)

alendronate sodium (70 mg/1)

Linked Drug Pages (1)

FOSAMAX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9cc10d27-3960-41a0-9736-8fe902c6984f", "openfda": {"unii": ["2UY4M2U3RA"], "rxcui": ["904431", "904433"], "spl_set_id": ["14e931fd-2c5f-4d90-b7db-5980706f4a56"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BLISTER PACK (78206-135-01)", "package_ndc": "78206-135-01", "marketing_start_date": "20210601"}], "brand_name": "FOSAMAX", "product_id": "78206-135_9cc10d27-3960-41a0-9736-8fe902c6984f", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "78206-135", "generic_name": "alendronate sodium", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FOSAMAX", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/1"}], "application_number": "NDA020560", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}