risedronate sodium

Generic: risedronate sodium

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risedronate sodium
Generic Name risedronate sodium
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risedronate sodium 35 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-109
Product ID 33342-109_7a6cb0e7-820c-4233-a7fa-d56c62f72ca3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203533
Listing Expiration 2027-12-31
Marketing Start 2015-12-09

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342109
Hyphenated Format 33342-109

Supplemental Identifiers

RxCUI
905024 905032 905041 905092 905100
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 ANDA203533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (33342-109-37) / 4 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (33342-109-50) / 4 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

33342-109-37 1 BLISTER PACK in 1 CARTON (33342-109-37) / 4 TABLET, FILM COATED in 1 BLISTER PACK 33342-109-50 3 BLISTER PACK in 1 CARTON (33342-109-50) / 4 TABLET, FILM COATED in 1 BLISTER PACK

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": "7a6cb0e7-820c-4233-a7fa-d56c62f72ca3", "openfda": {"unii": ["OFG5EXG60L"], "rxcui": ["905024", "905032", "905041", "905092", "905100"], "spl_set_id": ["62aff8d6-a2f7-4c7e-a102-c70105ac3792"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-109-37)  / 4 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-109-37", "marketing_start_date": "20151209"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (33342-109-50)  / 4 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-109-50", "marketing_start_date": "20151209"}], "brand_name": "Risedronate Sodium", "product_id": "33342-109_7a6cb0e7-820c-4233-a7fa-d56c62f72ca3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "33342-109", "generic_name": "Risedronate Sodium", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risedronate Sodium", "active_ingredients": [{"name": "RISEDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA203533", "marketing_category": "ANDA", "marketing_start_date": "20151209", "listing_expiration_date": "20271231"}