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, DELAYED RELEASE
Routes
ORAL
Active Ingredients

risedronate sodium hemipentahydrate 30.1 mg/1, risedronate sodium monohydrate 4.9 mg/1

Manufacturer
Mylan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 59762-0407
Product ID 59762-0407_38140640-1e32-4a68-8d8d-3eb52ab4af01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022560
Listing Expiration 2026-12-31
Marketing Start 2018-03-02

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597620407
Hyphenated Format 59762-0407

Supplemental Identifiers

RxCUI
1020064 1020065
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 NDA022560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30.1 mg/1
  • 4.9 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59762-0407-4) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

59762-0407-4 1 BLISTER PACK in 1 CARTON (59762-0407-4) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (2)

risedronate sodium hemipentahydrate (30.1 mg/1) risedronate sodium monohydrate (4.9 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": "38140640-1e32-4a68-8d8d-3eb52ab4af01", "openfda": {"unii": ["HU2YAQ274O", "F67L43UT5C"], "rxcui": ["1020064", "1020065"], "spl_set_id": ["c89430be-15f1-4b8b-ab7e-738de716ee7d"], "manufacturer_name": ["Mylan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59762-0407-4)  / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "59762-0407-4", "marketing_start_date": "20180302"}], "brand_name": "Risedronate Sodium", "product_id": "59762-0407_38140640-1e32-4a68-8d8d-3eb52ab4af01", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Bisphosphonate [EPC]", "Bisphosphonate [EPC]", "Diphosphonates [CS]", "Diphosphonates [CS]"], "product_ndc": "59762-0407", "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": "30.1 mg/1"}, {"name": "RISEDRONATE SODIUM MONOHYDRATE", "strength": "4.9 mg/1"}], "application_number": "NDA022560", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180302", "listing_expiration_date": "20261231"}