binosto

Generic: alendronate sodium

Labeler: radius health, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name binosto
Generic Name alendronate sodium
Labeler radius health, inc.
Dosage Form TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients

alendronate sodium 91.37 mg/1

Manufacturer
Radius Health, Inc.

Identifiers & Regulatory

Product NDC 70539-400
Product ID 70539-400_1ff6288a-ab6b-4443-81bd-fd1a37a2bd16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202344
Listing Expiration 2027-12-31
Marketing Start 2012-03-12

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70539400
Hyphenated Format 70539-400

Supplemental Identifiers

RxCUI
1248077 1248083
UPC
0370539400009
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 binosto (source: ndc)
Generic Name alendronate sodium (source: ndc)
Application Number NDA202344 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 91.37 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)
  • 4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)
source: ndc

Packages (2)

70539-400-04 4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00) 70539-400-94 4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)

Ingredients (1)

alendronate sodium (91.37 mg/1)

Linked Drug Pages (1)

Binosto ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ff6288a-ab6b-4443-81bd-fd1a37a2bd16", "openfda": {"upc": ["0370539400009"], "unii": ["2UY4M2U3RA"], "rxcui": ["1248077", "1248083"], "spl_set_id": ["09765234-01bc-40f7-b9bb-c167056f3909"], "manufacturer_name": ["Radius Health, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 BOX (70539-400-04)  / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)", "package_ndc": "70539-400-04", "marketing_start_date": "20120312"}, {"sample": false, "description": "4 BLISTER PACK in 1 BOX (70539-400-94)  / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)", "package_ndc": "70539-400-94", "marketing_start_date": "20230312"}], "brand_name": "Binosto", "product_id": "70539-400_1ff6288a-ab6b-4443-81bd-fd1a37a2bd16", "dosage_form": "TABLET, EFFERVESCENT", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "70539-400", "generic_name": "alendronate sodium", "labeler_name": "Radius Health, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Binosto", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "91.37 mg/1"}], "application_number": "NDA202344", "marketing_category": "NDA", "marketing_start_date": "20120312", "listing_expiration_date": "20271231"}