FDA.reportPublic FDA data

DOXIL

Product NDC
0338-9667
11-digit product format
003389667
Labeler code
0338
Product ID
0338-9667_4a616d65-765b-401c-abf3-8135df106493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA050718
Marketing category
NDA
Marketing start
2024-08-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82F2G7BL4E
Rxcui1790115, 1790127, 1790128, 1790131

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
0338-9667-01DOXIL10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION, LIPOSOMAL105
0338-9667-01DOXIL1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9667-01ML - Milliliter0338-966793c8ffd3-890b-4247-b558-8c681653746b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9667DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE CORPORATION]1Current NDC, 2 package rows20240829_917eddf9-1d3f-4abe-8c81-d33b066e5bae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790131Doxil 20 MG in 10 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790128Doxil 50 MG in 25 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179013110 ML doxorubicin hydrochloride liposome 2 MG/ML Injection [Doxil]SBD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179012825 ML doxorubicin hydrochloride liposome 2 MG/ML Injection [Doxil]SBD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790131Doxil 20 MG per 10 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790128Doxil 50 MG per 25 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0338-9667-01003389667011 VIAL, SINGLE-DOSE in 1 CARTON (0338-9667-01) / 10 mL in 1 VIAL, SINGLE-DOSE2024-08-26NoNoCurrent