ibandronate sodium

Generic: ibandronate sodium

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibandronate sodium
Generic Name ibandronate sodium
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ibandronate sodium 3 mg/3mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-524
Product ID 67457-524_270c89b1-757a-41ef-8067-d9034a4bdc9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202671
Marketing Start 2014-09-02
Marketing End 2026-05-31

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457524
Hyphenated Format 67457-524

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 ANDA202671 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (67457-524-33) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

67457-524-33 1 SYRINGE, GLASS in 1 CARTON (67457-524-33) / 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": "270c89b1-757a-41ef-8067-d9034a4bdc9e", "openfda": {"unii": ["J12U072QL0"], "rxcui": ["904952"], "spl_set_id": ["a70566e1-cbe5-472a-85ae-08a14117552a"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (67457-524-33)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "67457-524-33", "marketing_end_date": "20260531", "marketing_start_date": "20140902"}], "brand_name": "ibandronate sodium", "product_id": "67457-524_270c89b1-757a-41ef-8067-d9034a4bdc9e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "67457-524", "generic_name": "ibandronate sodium", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ibandronate sodium", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "3 mg/3mL"}], "application_number": "ANDA202671", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20140902"}