risedronate sodium

Generic: risedronate sodium

Labeler: sun pharmaceutical industires inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risedronate sodium
Generic Name risedronate sodium
Labeler sun pharmaceutical industires inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

risedronate sodium 35 mg/1

Manufacturer
Sun Pharmaceutical Industires Inc.

Identifiers & Regulatory

Product NDC 63304-440
Product ID 63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203925
Listing Expiration 2026-12-31
Marketing Start 2019-07-10

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304440
Hyphenated Format 63304-440

Supplemental Identifiers

RxCUI
1020064 1020065
UNII
OFG5EXG60L

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 ANDA203925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)
source: ndc

Packages (1)

63304-440-09 1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)

Ingredients (1)

risedronate sodium (35 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": "d97c9e6a-01e9-46ae-9088-0ca86b4eb842", "openfda": {"unii": ["OFG5EXG60L"], "rxcui": ["1020064", "1020065"], "spl_set_id": ["1d9e520b-2fa6-4603-b397-f0fc24fae775"], "manufacturer_name": ["Sun Pharmaceutical Industires Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 DOSE PACK in 1 CARTON (63304-440-09)  / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)", "package_ndc": "63304-440-09", "marketing_start_date": "20190710"}], "brand_name": "RISEDRONATE SODIUM", "product_id": "63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "63304-440", "generic_name": "RISEDRONATE SODIUM", "labeler_name": "Sun Pharmaceutical Industires Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISEDRONATE SODIUM", "active_ingredients": [{"name": "RISEDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA203925", "marketing_category": "ANDA", "marketing_start_date": "20190710", "listing_expiration_date": "20261231"}