doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

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

Drug Facts

Product Profile

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

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9091
Product ID 0143-9091_7c916380-3ae0-4a64-945d-7b0da46b9715
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064097
Listing Expiration 2026-12-31
Marketing Start 1996-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439091
Hyphenated Format 0143-9091

Supplemental Identifiers

RxCUI
1191138 1790097 1790099 1790100
UNII
82F2G7BL4E

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 doxorubicin hydrochloride (source: ndc)
Generic Name doxorubicin hydrochloride (source: ndc)
Application Number ANDA064097 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BOX (0143-9091-01) / 100 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0143-9091-01 1 VIAL, MULTI-DOSE in 1 BOX (0143-9091-01) / 100 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

doxorubicin hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Doxorubicin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7c916380-3ae0-4a64-945d-7b0da46b9715", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1191138", "1790097", "1790099", "1790100"], "spl_set_id": ["971de64b-ff09-4370-afd9-6eb1093ad27d"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (0143-9091-01)  / 100 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0143-9091-01", "marketing_start_date": "20191001"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "0143-9091_7c916380-3ae0-4a64-945d-7b0da46b9715", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0143-9091", "generic_name": "Doxorubicin Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA064097", "marketing_category": "ANDA", "marketing_start_date": "19960501", "listing_expiration_date": "20261231"}