FDA.reportPublic FDA data

Doxorubicin Hydrochloride Liposome

Product NDC
25021-263
11-digit product format
250210263
Labeler code
25021
Product ID
25021-263_97cdef7c-93c7-4c7a-9a51-fc260a6a4521
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxorubicin Hydrochloride
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA219881
Marketing category
ANDA
Marketing start
2026-03-01
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 Liposome
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
25021-263-10Doxorubicin Hydrochloride Liposome1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL11
25021-263-10Doxorubicin Hydrochloride Liposome10 mL in 1 VIALINJECTION, SUSPENSION, LIPOSOMAL101
25021-263-25Doxorubicin Hydrochloride Liposome1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL11
25021-263-25Doxorubicin Hydrochloride Liposome25 mL in 1 VIALINJECTION, SUSPENSION, LIPOSOMAL251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-263-10ML - Milliliter25021-263d6023115-bc28-4e93-9c55-61bab1449b8d12026-04-20
25021-263-25ML - Milliliter25021-263b06a467c-d336-448b-b437-5e7b1cdfd27412026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNc8eb4784-36e0-483f-9e5d-af0552e49bb51
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNc8eb4784-36e0-483f-9e5d-af0552e49bb51
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDc8eb4784-36e0-483f-9e5d-af0552e49bb51
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDc8eb4784-36e0-483f-9e5d-af0552e49bb51
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYc8eb4784-36e0-483f-9e5d-af0552e49bb51
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYc8eb4784-36e0-483f-9e5d-af0552e49bb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-263-10250210263101 VIAL in 1 CARTON (25021-263-10) / 10 mL in 1 VIAL1 vial2026-03-01NoNoCurrent
25021-263-25250210263251 VIAL in 1 CARTON (25021-263-25) / 25 mL in 1 VIAL1 vial2026-03-01NoNoCurrent