ibandronate sodium

Generic: ibandronate sodium

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ibandronate sodium 3 mg/3mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-191
Product ID 55150-191_9e93dc68-5558-4271-9f1f-44f4313babae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205332
Listing Expiration 2027-12-31
Marketing Start 2015-08-19

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150191
Hyphenated Format 55150-191

Supplemental Identifiers

RxCUI
904952
UPC
0355150191833
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 ANDA205332 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

55150-191-83 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) / 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": "9e93dc68-5558-4271-9f1f-44f4313babae", "openfda": {"upc": ["0355150191833"], "unii": ["J12U072QL0"], "rxcui": ["904952"], "spl_set_id": ["e81f2c5b-bead-48ac-be3e-016cf963d7ed"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (55150-191-83)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "55150-191-83", "marketing_start_date": "20150819"}], "brand_name": "Ibandronate Sodium", "product_id": "55150-191_9e93dc68-5558-4271-9f1f-44f4313babae", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "55150-191", "generic_name": "Ibandronate Sodium", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibandronate Sodium", "active_ingredients": [{"name": "IBANDRONATE SODIUM", "strength": "3 mg/3mL"}], "application_number": "ANDA205332", "marketing_category": "ANDA", "marketing_start_date": "20150819", "listing_expiration_date": "20271231"}