doxorubicin hydrochloride

Product NDC
75907-364
11-digit product format
759070364
Labeler code
75907
Product ID
75907-364_0885dddf-727e-4692-92dd-a26c69cc278d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA219199
Marketing category
ANDA
Marketing start
2025-06-27
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-364-01doxorubicin hydrochloride25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION, LIPOSOMAL251
75907-364-01doxorubicin hydrochloride1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-364-01ML - Milliliter75907-364ef764e16-b9c9-4dc1-8739-1dc27539b4fe12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSN0885dddf-727e-4692-92dd-a26c69cc278d1
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSN0885dddf-727e-4692-92dd-a26c69cc278d1
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD0885dddf-727e-4692-92dd-a26c69cc278d1
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD0885dddf-727e-4692-92dd-a26c69cc278d1
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSY0885dddf-727e-4692-92dd-a26c69cc278d1
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSY0885dddf-727e-4692-92dd-a26c69cc278d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75907-364-01759070364011 VIAL, SINGLE-DOSE in 1 CARTON (75907-364-01) / 25 mL in 1 VIAL, SINGLE-DOSE2025-06-27NoNoHistorical