FDA.reportPublic FDA data

doxorubicin hydrochloride, Liposomal

Product NDC
0338-9581
11-digit product format
003389581
Labeler code
0338
Product ID
0338-9581_a4227051-225f-49e2-9e5c-653ea0f99739
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2023-12-19
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, Liposomal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82F2G7BL4E
Rxcui1790115

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
0338-9581-01doxorubicin hydrochloride, Liposomal10 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, LIPOSOMAL103
0338-9581-02doxorubicin hydrochloride, Liposomal1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9581DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE CORPORATION]2Current NDC, 2 package rows20241101_b24afa8c-636b-4ace-99d5-51f445ad3123.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNb24afa8c-636b-4ace-99d5-51f445ad31233
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDb24afa8c-636b-4ace-99d5-51f445ad31233
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYb24afa8c-636b-4ace-99d5-51f445ad31233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9581-010033895810110 mL in 1 VIAL, SINGLE-USE10 mlHistorical
0338-9581-02003389581021 VIAL, SINGLE-USE in 1 CARTON (0338-9581-02) / 10 mL in 1 VIAL, SINGLE-USE (0338-9581-01) 2023-12-19NoNoCurrent