doxil

Generic: doxorubicin hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxil
Generic Name doxorubicin hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION, SUSPENSION, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-9665
Product ID 0338-9665_bfc1b628-0b1c-4262-b80b-7e5505c8f112
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050718
Listing Expiration 2027-12-31
Marketing Start 2024-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389665
Hyphenated Format 0338-9665

Supplemental Identifiers

RxCUI
1790115 1790127 1790128 1790131
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 doxil (source: ndc)
Generic Name doxorubicin hydrochloride (source: ndc)
Application Number NDA050718 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9665-01) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0338-9665-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9665-01) / 25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

doxorubicin hydrochloride (2 mg/mL)

Linked Drug Pages (1)

DOXIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "bfc1b628-0b1c-4262-b80b-7e5505c8f112", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127", "1790128", "1790131"], "spl_set_id": ["917eddf9-1d3f-4abe-8c81-d33b066e5bae"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9665-01)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0338-9665-01", "marketing_start_date": "20240826"}], "brand_name": "DOXIL", "product_id": "0338-9665_bfc1b628-0b1c-4262-b80b-7e5505c8f112", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0338-9665", "generic_name": "doxorubicin hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXIL", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA050718", "marketing_category": "NDA", "marketing_start_date": "20240826", "listing_expiration_date": "20271231"}