FDA.reportPublic FDA data

Doxorubicin Hydrochloride

Product NDC
68001-492
11-digit product format
680010492
Labeler code
68001
Product ID
68001-492_525648ca-bf98-83d3-e063-6394a90a651b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA203263
Marketing category
ANDA
Marketing start
2021-05-31
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
68001-492-36Doxorubicin Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL105
68001-492-36Doxorubicin Hydrochloride1 in 1 PACKAGEINJECTABLE, LIPOSOMAL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-492-36ML - Milliliter68001-49216781aaa-494a-4c99-a856-f509f12e70f512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-492DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20241016_f6508535-e7a7-4e50-8d0c-43deda8d0d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNf6508535-e7a7-4e50-8d0c-43deda8d0d085
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNf6508535-e7a7-4e50-8d0c-43deda8d0d085
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDf6508535-e7a7-4e50-8d0c-43deda8d0d085
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDf6508535-e7a7-4e50-8d0c-43deda8d0d085
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYf6508535-e7a7-4e50-8d0c-43deda8d0d085
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYf6508535-e7a7-4e50-8d0c-43deda8d0d085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-492-36680010492361 VIAL, SINGLE-DOSE in 1 PACKAGE (68001-492-36) / 10 mL in 1 VIAL, SINGLE-DOSE2021-05-310000-00-00NoNoCurrent