FDA.reportPublic FDA data

Doxorubicin Hydrochloride

Product NDC
72603-103
11-digit product format
726030103
Labeler code
72603
Product ID
72603-103_010a4e76-dedf-4f7b-b4de-1d78f91c2095
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
NorthStar RxLLC
Application
ANDA203263
Marketing category
ANDA
Marketing start
2019-05-29
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
Doxorubicin Hydrochloride
Listing expiration
2027-12-31

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
72603-103-01Doxorubicin Hydrochloride1 in 1 PACKAGEINJECTABLE, LIPOSOMAL18
72603-103-01Doxorubicin Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-103DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [NORTHSTAR RXLLC]7Current NDC, Legacy NDC, 2 package rows20250503_ddf55319-bf62-4ec7-8be2-ef97188837c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNddf55319-bf62-4ec7-8be2-ef97188837c48
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNddf55319-bf62-4ec7-8be2-ef97188837c48
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDddf55319-bf62-4ec7-8be2-ef97188837c48
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDddf55319-bf62-4ec7-8be2-ef97188837c48
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYddf55319-bf62-4ec7-8be2-ef97188837c48
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYddf55319-bf62-4ec7-8be2-ef97188837c48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72603-103-01726030103011 VIAL, SINGLE-DOSE in 1 PACKAGE (72603-103-01) / 10 mL in 1 VIAL, SINGLE-DOSE2019-05-290000-00-00NoNoCurrent