FDA.reportPublic FDA data

Doxorubicin Hydrochloride Liposome

Product NDC
0338-0080
11-digit product format
003380080
Labeler code
0338
Product ID
0338-0080_dc55e584-6c92-4cd3-ad37-25029cf15368
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride Liposome
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA050718
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-08-15
Substance
DOXORUBICIN HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxorubicin Hydrochloride Liposome
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82F2G7BL4E
Rxcui1790115, 1790127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0080-01Doxorubicin Hydrochloride Liposome1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL110
0338-0080-01Doxorubicin Hydrochloride Liposome10 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, LIPOSOMAL1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0080-01ML - Milliliter0338-00808d3052e9-1eaf-4e7a-bed5-69b4982aef9112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0080DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE COMPANY]9Current NDC, Legacy NDC, 2 package rows20250430_cf25a018-e795-49e4-8533-a581f8366dd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNcf25a018-e795-49e4-8533-a581f8366dd910
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNcf25a018-e795-49e4-8533-a581f8366dd910
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDcf25a018-e795-49e4-8533-a581f8366dd910
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDcf25a018-e795-49e4-8533-a581f8366dd910
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYcf25a018-e795-49e4-8533-a581f8366dd910
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYcf25a018-e795-49e4-8533-a581f8366dd910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0338-0080-01003380080011 VIAL, SINGLE-USE in 1 CARTON (0338-0080-01) / 10 mL in 1 VIAL, SINGLE-USE2019-08-150000-00-00NoNoCurrent