doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0358
Product ID 0069-0358_1e8e701d-b982-4671-b1ab-38b56826f23f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050629
Listing Expiration 2026-12-31
Marketing Start 2024-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690358
Hyphenated Format 0069-0358

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 NDA050629 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0069-0358-20) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0069-0358-20 1 VIAL, SINGLE-DOSE in 1 CARTON (0069-0358-20) / 5 mL in 1 VIAL, SINGLE-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": "1e8e701d-b982-4671-b1ab-38b56826f23f", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1191138", "1790097", "1790099", "1790100"], "spl_set_id": ["1fd148fb-0fbc-4b6f-b790-23546fb46a71"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0069-0358-20)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0069-0358-20", "marketing_start_date": "20240819"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "0069-0358_1e8e701d-b982-4671-b1ab-38b56826f23f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0069-0358", "generic_name": "Doxorubicin Hydrochloride", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA050629", "marketing_category": "NDA", "marketing_start_date": "20240819", "listing_expiration_date": "20261231"}