ibandronate sodium

Generic: ibandronate sodium

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibandronate sodium
Generic Name ibandronate sodium
Labeler bionpharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibandronate sodium 150 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-378
Product ID 69452-378_7c860070-7f7a-4217-9cfb-f5536fd736b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078998
Listing Expiration 2026-12-31
Marketing Start 2023-05-26

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452378
Hyphenated Format 69452-378

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 ANDA078998 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69452-378-74) / 3 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

69452-378-74 1 BLISTER PACK in 1 CARTON (69452-378-74) / 3 TABLET 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": "7c860070-7f7a-4217-9cfb-f5536fd736b4", "openfda": {"unii": ["J12U072QL0"], "rxcui": ["904932"], "spl_set_id": ["6ca94cce-a2bb-421f-bd8f-6b14bc2bd985"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69452-378-74)  / 3 TABLET in 1 BLISTER PACK", "package_ndc": "69452-378-74", "marketing_start_date": "20230526"}], "brand_name": "IBANDRONATE SODIUM", "product_id": "69452-378_7c860070-7f7a-4217-9cfb-f5536fd736b4", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "69452-378", "generic_name": "IBANDRONATE SODIUM", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IBANDRONATE SODIUM", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "150 mg/1"}], "application_number": "ANDA078998", "marketing_category": "ANDA", "marketing_start_date": "20230526", "listing_expiration_date": "20261231"}