ibandronate sodium

Generic: ibandronate sodium

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibandronate sodium
Generic Name ibandronate sodium
Labeler dr. reddy's laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibandronate sodium 150 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-575
Product ID 55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078997
Listing Expiration 2026-12-31
Marketing Start 2012-06-21

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111575
Hyphenated Format 55111-575

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 ANDA078997 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11)
  • 1 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13)
source: ndc

Packages (2)

55111-575-03 3 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11) 55111-575-43 1 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13)

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": "eeeb1802-6fe6-ebb0-2df8-98b42385b89f", "openfda": {"unii": ["J12U072QL0"], "rxcui": ["904932"], "spl_set_id": ["f94d9c49-245a-8081-42c4-785113fce498"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (55111-575-03)  / 1 TABLET in 1 BLISTER PACK (55111-575-11)", "package_ndc": "55111-575-03", "marketing_start_date": "20120621"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55111-575-43)  / 3 TABLET in 1 BLISTER PACK (55111-575-13)", "package_ndc": "55111-575-43", "marketing_start_date": "20211120"}], "brand_name": "Ibandronate sodium", "product_id": "55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "55111-575", "generic_name": "Ibandronate sodium", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibandronate sodium", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "150 mg/1"}], "application_number": "ANDA078997", "marketing_category": "ANDA", "marketing_start_date": "20120621", "listing_expiration_date": "20261231"}