FDA.reportPublic FDA data

Doxorubicin Hydrochloride

Product NDC
43598-541
11-digit product format
435980541
Labeler code
43598
Product ID
43598-541_c879ca79-919e-693e-4712-72c8ccf42813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTABLE, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA208657
Marketing category
ANDA
Marketing start
2017-05-22
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
43598-541-25Doxorubicin Hydrochloride25 mL in 1 VIAL, SINGLE-DOSEINJECTABLE, LIPOSOMAL259
43598-541-25Doxorubicin Hydrochloride1 in 1 CARTONINJECTABLE, LIPOSOMAL19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-541-25ML - Milliliter43598-541f7379791-0ea7-4783-8177-be34d3485d7712017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-541DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [DR. REDDY'S LABORATORIES INC]9Current NDC, Legacy NDC, 2 package rows20230411_f5910862-f565-a685-2f3e-9d6e676c381b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNf5910862-f565-a685-2f3e-9d6e676c381b9
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNf5910862-f565-a685-2f3e-9d6e676c381b9
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDf5910862-f565-a685-2f3e-9d6e676c381b9
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDf5910862-f565-a685-2f3e-9d6e676c381b9
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYf5910862-f565-a685-2f3e-9d6e676c381b9
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYf5910862-f565-a685-2f3e-9d6e676c381b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-541-25435980541251 VIAL, SINGLE-DOSE in 1 CARTON (43598-541-25) / 25 mL in 1 VIAL, SINGLE-DOSE2017-05-220000-00-00NoNoCurrent