risedronate sodium

Generic: risedronate sodium

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risedronate sodium
Generic Name risedronate sodium
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risedronate sodium 150 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3097
Product ID 60505-3097_03750616-5c88-729a-215e-3d796f8ba6a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090877
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 605053097
Hyphenated Format 60505-3097

Supplemental Identifiers

RxCUI
905024 905028 905083
UPC
0360505309627
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 ANDA090877 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (60505-3097-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (60505-3097-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

60505-3097-2 1 BLISTER PACK in 1 CARTON (60505-3097-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK 60505-3097-4 1 BLISTER PACK in 1 CARTON (60505-3097-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

risedronate sodium (150 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": "03750616-5c88-729a-215e-3d796f8ba6a8", "openfda": {"upc": ["0360505309627"], "unii": ["OFG5EXG60L"], "rxcui": ["905024", "905028", "905083"], "spl_set_id": ["b90f2e5b-10b8-29a7-0360-31bd0dae0ec2"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (60505-3097-2)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "60505-3097-2", "marketing_start_date": "20140611"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (60505-3097-4)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "60505-3097-4", "marketing_start_date": "20140611"}], "brand_name": "Risedronate Sodium", "product_id": "60505-3097_03750616-5c88-729a-215e-3d796f8ba6a8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "60505-3097", "generic_name": "Risedronate Sodium", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risedronate Sodium", "active_ingredients": [{"name": "RISEDRONATE SODIUM", "strength": "150 mg/1"}], "application_number": "ANDA090877", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20271231"}