idarubicin hydrochloride

Generic: idarubicin hydrochloride

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

Drug Facts

Product Profile

Brand Name idarubicin hydrochloride
Generic Name idarubicin hydrochloride
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

idarubicin hydrochloride 1 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-186
Product ID 71288-186_677002b4-7b30-4d32-ae99-5ee630c5b5fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065036
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Classes
anthracycline topoisomerase inhibitor [epc] anthracyclines [cs] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288186
Hyphenated Format 71288-186

Supplemental Identifiers

RxCUI
1791493 1791498 1791500
UNII
5VV3MDU5IE

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 idarubicin hydrochloride (source: ndc)
Generic Name idarubicin hydrochloride (source: ndc)
Application Number ANDA065036 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-186-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-186-20 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-186-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

idarubicin hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Idarubicin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "677002b4-7b30-4d32-ae99-5ee630c5b5fb", "openfda": {"unii": ["5VV3MDU5IE"], "rxcui": ["1791493", "1791498", "1791500"], "spl_set_id": ["d31254be-6bd2-4ac1-acab-bc00e2209d28"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-186-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-186-20", "marketing_start_date": "20250601"}], "brand_name": "Idarubicin Hydrochloride", "product_id": "71288-186_677002b4-7b30-4d32-ae99-5ee630c5b5fb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "71288-186", "generic_name": "Idarubicin Hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Idarubicin Hydrochloride", "active_ingredients": [{"name": "IDARUBICIN HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA065036", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}