idarubicin hydrochloride

Generic: idarubicin hydrochloride

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

Drug Facts

Product Profile

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

idarubicin hydrochloride 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9306
Product ID 0143-9306_c78bf879-433f-4805-ad7b-5fa3002a75db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065275
Listing Expiration 2026-12-31
Marketing Start 2018-01-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439306
Hyphenated Format 0143-9306

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 ANDA065275 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 BOX (0143-9306-01) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0143-9306-01 1 VIAL, GLASS in 1 BOX (0143-9306-01) / 5 mL in 1 VIAL, GLASS

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": "c78bf879-433f-4805-ad7b-5fa3002a75db", "openfda": {"unii": ["5VV3MDU5IE"], "rxcui": ["1791493", "1791498", "1791500"], "spl_set_id": ["7c20b574-285b-49eb-a98e-6752e4bb481d"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 BOX (0143-9306-01)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "0143-9306-01", "marketing_start_date": "20180112"}], "brand_name": "Idarubicin Hydrochloride", "product_id": "0143-9306_c78bf879-433f-4805-ad7b-5fa3002a75db", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0143-9306", "generic_name": "Idarubicin Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Idarubicin Hydrochloride", "active_ingredients": [{"name": "IDARUBICIN HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA065275", "marketing_category": "ANDA", "marketing_start_date": "20180112", "listing_expiration_date": "20261231"}