FDA.reportPublic FDA data

DOXORUBICIN HYDROCHLORIDE

Product NDC
70748-339
11-digit product format
707480339
Labeler code
70748
Product ID
70748-339_e9f76142-15d0-4234-8f2e-5f5014160eff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXORUBICIN HYDROCHLORIDE
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA215178
Marketing category
ANDA
Marketing start
2024-08-26
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
70748-339-01DOXORUBICIN HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, LIPOSOMAL104
70748-339-01DOXORUBICIN HYDROCHLORIDE1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-339DOXORUBICIN HYDROCHLORIDE INJECTION, SUSPENSION, LIPOSOMAL [LUPIN PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20240927_0f8eb9a1-74d0-47fd-94b8-a65b29006521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSN0f8eb9a1-74d0-47fd-94b8-a65b290065214
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSN0f8eb9a1-74d0-47fd-94b8-a65b290065214
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD0f8eb9a1-74d0-47fd-94b8-a65b290065214
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD0f8eb9a1-74d0-47fd-94b8-a65b290065214
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSY0f8eb9a1-74d0-47fd-94b8-a65b290065214
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSY0f8eb9a1-74d0-47fd-94b8-a65b290065214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70748-339-01707480339011 VIAL, SINGLE-USE in 1 CARTON (70748-339-01) / 10 mL in 1 VIAL, SINGLE-USE2024-08-26NoNoCurrent