risedronate sodium

Generic: risedronate sodium

Labeler: mylan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
Mylan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 59762-0406
Product ID 59762-0406_a5de8cc0-48ec-41cc-99f1-87f1c432096d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
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 597620406
Hyphenated Format 59762-0406

Supplemental Identifiers

RxCUI
905024 905028 905092 905100
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 risedronate sodium (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 (59762-0406-1)
source: ndc

Packages (1)

59762-0406-1 1 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1)

Ingredients (2)

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

Linked Drug Pages (1)

Risedronate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a5de8cc0-48ec-41cc-99f1-87f1c432096d", "openfda": {"unii": ["HU2YAQ274O", "F67L43UT5C"], "rxcui": ["905024", "905028", "905092", "905100"], "spl_set_id": ["f715718a-407d-4e2a-9834-74a8f1361d03"], "manufacturer_name": ["Mylan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1)", "package_ndc": "59762-0406-1", "marketing_start_date": "20080422"}], "brand_name": "Risedronate Sodium", "product_id": "59762-0406_a5de8cc0-48ec-41cc-99f1-87f1c432096d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Bisphosphonate [EPC]", "Diphosphonates [CS]", "Diphosphonates [CS]"], "product_ndc": "59762-0406", "generic_name": "Risedronate Sodium", "labeler_name": "Mylan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risedronate Sodium", "active_ingredients": [{"name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE", "strength": "129 mg/1"}, {"name": "RISEDRONATE SODIUM MONOHYDRATE", "strength": "21 mg/1"}], "application_number": "NDA020835", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20080422", "listing_expiration_date": "20271231"}