ibandronate sodium

Generic: ibandronate sodium

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

Drug Facts

Product Profile

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

ibandronate sodium 150 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-2795
Product ID 60505-2795_31cdb988-ed22-4f0d-d1c2-8e89aae8c703
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078948
Listing Expiration 2027-12-31
Marketing Start 2012-03-19

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605052795
Hyphenated Format 60505-2795

Supplemental Identifiers

RxCUI
904932
UNII
J12U072QL0

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 ibandronate sodium (source: ndc)
Generic Name ibandronate sodium (source: ndc)
Application Number ANDA078948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 PACKAGE (60505-2795-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

60505-2795-0 3 BLISTER PACK in 1 PACKAGE (60505-2795-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ibandronate sodium (150 mg/1)

Linked Drug Pages (1)

IBANDRONATE SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31cdb988-ed22-4f0d-d1c2-8e89aae8c703", "openfda": {"unii": ["J12U072QL0"], "rxcui": ["904932"], "spl_set_id": ["dd674424-b151-d7eb-3acf-b1589347f2f7"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 PACKAGE (60505-2795-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "60505-2795-0", "marketing_start_date": "20120319"}], "brand_name": "IBANDRONATE SODIUM", "product_id": "60505-2795_31cdb988-ed22-4f0d-d1c2-8e89aae8c703", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "60505-2795", "generic_name": "IBANDRONATE SODIUM", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IBANDRONATE SODIUM", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "150 mg/1"}], "application_number": "ANDA078948", "marketing_category": "ANDA", "marketing_start_date": "20120319", "listing_expiration_date": "20271231"}