doxil

Generic: doxorubicin hydrochloride

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

Drug Facts

Product Profile

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

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-0067
Product ID 0338-0067_cd847039-f8ab-4b90-ba4b-724504063f6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050718
Listing Expiration 2026-12-31
Marketing Start 2019-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380067
Hyphenated Format 0338-0067

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
INTRAVITREAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0338-0067-01 1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 mL in 1 VIAL, SINGLE-USE

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": ["INTRAVITREAL"], "spl_id": "cd847039-f8ab-4b90-ba4b-724504063f6f", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127", "1790128", "1790131"], "spl_set_id": ["1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01)  / 25 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0338-0067-01", "marketing_start_date": "20190813"}], "brand_name": "DOXIL", "product_id": "0338-0067_cd847039-f8ab-4b90-ba4b-724504063f6f", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0338-0067", "generic_name": "doxorubicin hydrochloride", "labeler_name": "Baxter Healthcare Company", "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": "20190813", "listing_expiration_date": "20261231"}