risedronate sodium

Generic: risedronate sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

risedronate sodium 35 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-519
Product ID 65862-519_9488209f-f3ad-4726-be89-f6a7e59e6885
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200296
Listing Expiration 2027-12-31
Marketing Start 2015-11-30

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862519
Hyphenated Format 65862-519

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 ANDA200296 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-519-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (65862-519-08) / 4 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

65862-519-04 1 BLISTER PACK in 1 CARTON (65862-519-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK 65862-519-08 3 BLISTER PACK in 1 CARTON (65862-519-08) / 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": "9488209f-f3ad-4726-be89-f6a7e59e6885", "openfda": {"unii": ["OFG5EXG60L"], "rxcui": ["905024", "905032", "905041", "905092", "905100"], "spl_set_id": ["89896dfe-f69d-4cb3-bb71-7a7c611071fa"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-519-04)  / 4 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-519-04", "marketing_start_date": "20151130"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-519-08)  / 4 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-519-08", "marketing_start_date": "20151130"}], "brand_name": "Risedronate Sodium", "product_id": "65862-519_9488209f-f3ad-4726-be89-f6a7e59e6885", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "65862-519", "generic_name": "Risedronate Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risedronate Sodium", "active_ingredients": [{"name": "RISEDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA200296", "marketing_category": "ANDA", "marketing_start_date": "20151130", "listing_expiration_date": "20271231"}