actonel

Generic: risedronate sodium

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

Drug Facts

Product Profile

Brand Name actonel
Generic Name risedronate sodium
Labeler allergan, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risedronate sodium hemipentahydrate 129 mg/1, risedronate sodium monohydrate 21 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0430-0478
Product ID 0430-0478_a802b815-5397-4bc3-acba-5886e015c11f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020835
Listing Expiration 2027-12-31
Marketing Start 2008-04-22

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04300478
Hyphenated Format 0430-0478

Supplemental Identifiers

RxCUI
905024 905026 905028 905030 905032 905034 905041 905043 905083 905084 905086 905087 905092 905093 905100 905101
UNII
HU2YAQ274O F67L43UT5C

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 actonel (source: ndc)
Generic Name risedronate sodium (source: ndc)
Application Number NDA020835 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 129 mg/1
  • 21 mg/1
source: ndc
Packaging
  • 1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)
source: ndc

Packages (1)

0430-0478-01 1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)

Ingredients (2)

risedronate sodium hemipentahydrate (129 mg/1) risedronate sodium monohydrate (21 mg/1)

Linked Drug Pages (1)

Actonel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a802b815-5397-4bc3-acba-5886e015c11f", "openfda": {"unii": ["HU2YAQ274O", "F67L43UT5C"], "rxcui": ["905024", "905026", "905028", "905030", "905032", "905034", "905041", "905043", "905083", "905084", "905086", "905087", "905092", "905093", "905100", "905101"], "spl_set_id": ["24ed00e0-25e2-49a8-97fc-66c1b417dc0b"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)", "package_ndc": "0430-0478-01", "marketing_start_date": "20080422"}], "brand_name": "Actonel", "product_id": "0430-0478_a802b815-5397-4bc3-acba-5886e015c11f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Bisphosphonate [EPC]", "Diphosphonates [CS]", "Diphosphonates [CS]"], "product_ndc": "0430-0478", "generic_name": "Risedronate Sodium", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Actonel", "active_ingredients": [{"name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE", "strength": "129 mg/1"}, {"name": "RISEDRONATE SODIUM MONOHYDRATE", "strength": "21 mg/1"}], "application_number": "NDA020835", "marketing_category": "NDA", "marketing_start_date": "20080422", "listing_expiration_date": "20271231"}