ibandronate sodium

Generic: ibandronate sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibandronate sodium
Generic Name ibandronate sodium
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibandronate sodium 150 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-237
Product ID 65862-237_6d9a3f36-83b1-4d1b-ab7d-582b3551839b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204502
Listing Expiration 2027-12-31
Marketing Start 2016-03-11

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862237
Hyphenated Format 65862-237

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 ANDA204502 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-237-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

65862-237-03 1 BLISTER PACK in 1 CARTON (65862-237-03) / 3 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": "6d9a3f36-83b1-4d1b-ab7d-582b3551839b", "openfda": {"unii": ["J12U072QL0"], "rxcui": ["904932"], "spl_set_id": ["86c0b4ae-5e38-4efe-88af-50ac560e294f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-237-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-237-03", "marketing_start_date": "20160311"}], "brand_name": "Ibandronate Sodium", "product_id": "65862-237_6d9a3f36-83b1-4d1b-ab7d-582b3551839b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "65862-237", "generic_name": "Ibandronate Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibandronate Sodium", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "150 mg/1"}], "application_number": "ANDA204502", "marketing_category": "ANDA", "marketing_start_date": "20160311", "listing_expiration_date": "20271231"}