DOXIL

Product NDC
0338-9667
11-digit product format
003389667
Labeler code
0338
Product ID
0338-9667_4a616d65-765b-401c-abf3-8135df106493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA050718
Marketing category
NDA
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
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
N050718-001DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17
N050718-002DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050718-001AB
N050718-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050718-001DOXIL (LIPOSOMAL)20MG/10ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD1995-11-17782e0a99824c…
2021-12-28 21:50 UTC2021-12N050718-002DOXIL (LIPOSOMAL)50MG/25ML (2MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONABRLD2000-06-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050718-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050718-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050718-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050718-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050718-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050718-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050718-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050718-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050718-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050718-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050718-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050718-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050718-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050718-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050718-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050718-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050718-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050718-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050718-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050718-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050718-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050718-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050718-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050718-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050718-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050718-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050718-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050718-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050718-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
DOXIL
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1790115Internal RxNorm lookup
1790127Internal RxNorm lookup
1790128Internal RxNorm lookup
1790131Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
917eddf9-1d3f-4abe-8c81-d33b066e5baeAvailable 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
0338-9667-01DOXIL10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION, LIPOSOMAL105
0338-9667-01DOXIL1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9667-01ML - Milliliter0338-966793c8ffd3-890b-4247-b558-8c681653746b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9667DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE CORPORATION]1Current NDC, 2 package rows20240829_917eddf9-1d3f-4abe-8c81-d33b066e5bae.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXILDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Corporation917eddf9-1d3f-4abe-8c81-d33b066e5bae2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050718
application number: NDA050718
ndc (product): 0338-9667
DOXILDOXORUBICIN HYDROCHLORIDEBaxter Healthcare Company1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce2022-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050718
application number: NDA050718
Doxorubicin Hydrochloride LiposomeDOXORUBICIN HYDROCHLORIDE LIPOSOMEBaxter Healthcare Companycf25a018-e795-49e4-8533-a581f8366dd92022-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050718
application number: NDA050718

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790131Doxil 20 MG in 10 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790128Doxil 50 MG in 25 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSN917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179013110 ML doxorubicin hydrochloride liposome 2 MG/ML Injection [Doxil]SBD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179012825 ML doxorubicin hydrochloride liposome 2 MG/ML Injection [Doxil]SBD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCD917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790131Doxil 20 MG per 10 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790128Doxil 50 MG per 25 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSY917eddf9-1d3f-4abe-8c81-d33b066e5bae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0338-9667-01003389667011 VIAL, SINGLE-DOSE in 1 CARTON (0338-9667-01) / 10 mL in 1 VIAL, SINGLE-DOSE2024-08-26NoNoCurrent