risedronate sodium

Generic: risedronate sodium

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

Drug Facts

Product Profile

Brand Name risedronate sodium
Generic Name risedronate sodium
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risedronate sodium hemi-pentahydrate 75 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-727
Product ID 47335-727_a9910c38-e099-4f8a-a7e9-a88623be2032
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090886
Listing Expiration 2027-12-31
Marketing Start 2014-06-11

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335727
Hyphenated Format 47335-727

Supplemental Identifiers

RxCUI
905024 905028 905032 905041 905083 905092 905100
UPC
0347335727982
UNII
HU2YAQ274O

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 ANDA090886 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (47335-727-98) / 2 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

47335-727-98 1 BLISTER PACK in 1 CARTON (47335-727-98) / 2 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

risedronate sodium hemi-pentahydrate (75 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": "a9910c38-e099-4f8a-a7e9-a88623be2032", "openfda": {"upc": ["0347335727982"], "unii": ["HU2YAQ274O"], "rxcui": ["905024", "905028", "905032", "905041", "905083", "905092", "905100"], "spl_set_id": ["e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (47335-727-98)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "47335-727-98", "marketing_start_date": "20140611"}], "brand_name": "risedronate sodium", "product_id": "47335-727_a9910c38-e099-4f8a-a7e9-a88623be2032", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "47335-727", "generic_name": "risedronate sodium", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "risedronate sodium", "active_ingredients": [{"name": "RISEDRONATE SODIUM HEMI-PENTAHYDRATE", "strength": "75 mg/1"}], "application_number": "ANDA090886", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20271231"}