daunorubicin hydrochloride

Generic: daunorubicin hydrochloride

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

Drug Facts

Product Profile

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

daunorubicin hydrochloride 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9551
Product ID 0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050731
Listing Expiration 2026-12-31
Marketing Start 2018-01-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439551
Hyphenated Format 0143-9551

Supplemental Identifiers

RxCUI
309650 2002002
UNII
UD984I04LZ

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 daunorubicin hydrochloride (source: ndc)
Generic Name daunorubicin hydrochloride (source: ndc)
Application Number NDA050731 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01)
source: ndc

Packages (1)

0143-9551-10 10 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01)

Ingredients (1)

daunorubicin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Daunorubicin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d77dc365-6db8-4bdc-81fc-7ac80bcc7699", "openfda": {"unii": ["UD984I04LZ"], "rxcui": ["309650", "2002002"], "spl_set_id": ["227784a8-ce68-4dd4-8ac5-a65265969677"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (0143-9551-10)  / 4 mL in 1 VIAL (0143-9551-01)", "package_ndc": "0143-9551-10", "marketing_start_date": "20180102"}], "brand_name": "Daunorubicin Hydrochloride", "product_id": "0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699", "dosage_form": "INJECTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0143-9551", "generic_name": "Daunorubicin Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daunorubicin Hydrochloride", "active_ingredients": [{"name": "DAUNORUBICIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA050731", "marketing_category": "NDA", "marketing_start_date": "20180102", "listing_expiration_date": "20261231"}