FDA.reportPublic FDA data

Doxorubicin Hydrochloride

Product NDC
68001-345
11-digit product format
680010345
Labeler code
68001
Product ID
68001-345_e9b9ead5-4033-1599-e053-2a95a90a0d81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA208657
Marketing category
ANDA
Marketing start
2018-02-16
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
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
68001-345-26Doxorubicin Hydrochloride25 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL254
68001-345-26Doxorubicin Hydrochloride1 in 1 CARTONINJECTABLE, LIPOSOMAL14
68001-345-36Doxorubicin Hydrochloride1 in 1 CARTONINJECTABLE, LIPOSOMAL14
68001-345-36Doxorubicin Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-345-26ML - Milliliter68001-345c5bf0eaa-6308-453a-acd7-b495a709ff9c12018-04-19
68001-345-36ML - Milliliter68001-34542ac21aa-9cb2-4b26-bdf8-8d0f6ebabd2a12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-345DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 4 package rows20220929_f1a12eb5-5bdc-45f4-843e-0c971535b184.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNf1a12eb5-5bdc-45f4-843e-0c971535b1844
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNf1a12eb5-5bdc-45f4-843e-0c971535b1844
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDf1a12eb5-5bdc-45f4-843e-0c971535b1844
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDf1a12eb5-5bdc-45f4-843e-0c971535b1844
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYf1a12eb5-5bdc-45f4-843e-0c971535b1844
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYf1a12eb5-5bdc-45f4-843e-0c971535b1844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-345-26680010345261 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26) / 25 mL in 1 VIAL, SINGLE-DOSE2018-02-160000-00-00NoNoCurrent
68001-345-36680010345361 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-36) / 10 mL in 1 VIAL, SINGLE-DOSE2018-02-160000-00-00NoNoCurrent