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 INJECTION
Routes
INTRAVENOUS
Active Ingredients

ibandronate sodium 3 mg/3mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6097
Product ID 60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5dde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204222
Listing Expiration 2027-12-31
Marketing Start 2016-01-13

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056097
Hyphenated Format 60505-6097

Supplemental Identifiers

RxCUI
904952
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 ANDA204222 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

60505-6097-0 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASS

Ingredients (1)

ibandronate sodium (3 mg/3mL)

Linked Drug Pages (1)

Ibandronate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "63d90e35-b379-2511-e5fd-b75c1d1d5dde", "openfda": {"unii": ["J12U072QL0"], "rxcui": ["904952"], "spl_set_id": ["9fad4982-95af-d711-f50a-867311835143"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (60505-6097-0)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "60505-6097-0", "marketing_start_date": "20160113"}], "brand_name": "Ibandronate Sodium", "product_id": "60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5dde", "dosage_form": "INJECTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "60505-6097", "generic_name": "ibandronate sodium", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibandronate Sodium", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "3 mg/3mL"}], "application_number": "ANDA204222", "marketing_category": "ANDA", "marketing_start_date": "20160113", "listing_expiration_date": "20271231"}