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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219881-001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2026-02-03
A219881-002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2026-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219881-001AB
A219881-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219881-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2026-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219881-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2026-02-03011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219881-001DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2026-02-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219881-002DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAB2026-02-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219881-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219881-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219881-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219881-002AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82F2G7BL4EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1790115Internal RxNorm lookup
1790127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8eb4784-36e0-483f-9e5d-af0552e49bb5Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxorubicin Hydrochloride LiposomeDOXORUBICIN HYDROCHLORIDESagent Pharmaceuticalsc8eb4784-36e0-483f-9e5d-af0552e49bb52026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219881
application number: ANDA219881
ndc (product): 25021-263

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