doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-436
Product ID 67457-436_fa646028-c150-4d9b-80a8-8add851d684d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200170
Listing Expiration 2026-12-31
Marketing Start 2014-02-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457436
Hyphenated Format 67457-436

Supplemental Identifiers

RxCUI
1790095 1790103
UPC
0367457478104
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 ANDA200170 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-436-50) / 25 mL in 1 VIAL
source: ndc

Packages (1)

67457-436-50 1 VIAL in 1 CARTON (67457-436-50) / 25 mL in 1 VIAL

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": "fa646028-c150-4d9b-80a8-8add851d684d", "openfda": {"upc": ["0367457478104"], "unii": ["82F2G7BL4E"], "rxcui": ["1790095", "1790103"], "spl_set_id": ["5f71f79a-4f14-472d-b982-e28c3ce8f972"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-436-50)  / 25 mL in 1 VIAL", "package_ndc": "67457-436-50", "marketing_start_date": "20140227"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "67457-436_fa646028-c150-4d9b-80a8-8add851d684d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "67457-436", "generic_name": "Doxorubicin Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA200170", "marketing_category": "ANDA", "marketing_start_date": "20140227", "listing_expiration_date": "20261231"}