DOXIL

Product NDC: 0338-0067
11-digit product format: 003380067
Labeler code: 0338
Product ID: 0338-0067_cd847039-f8ab-4b90-ba4b-724504063f6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxorubicin hydrochloride
Dosage form: INJECTION, SUSPENSION, LIPOSOMAL
Route: INTRAVITREAL
Labeler: Baxter Healthcare Company
Application: NDA050718
Marketing category: NDA
Marketing start: 2019-08-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050718-001	DOXIL (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17
N050718-002	DOXIL (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13

Therapeutic equivalence codes#

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

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

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050718-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050718-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050718-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050718-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050718-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050718-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050718-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050718-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050718-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050718-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050718-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050718-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050718-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050718-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050718-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050718-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050718-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050718-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050718-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050718-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050718-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050718-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050718-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050718-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050718-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050718-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050718-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050718-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050718-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050718-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050718-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050718-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050718-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050718-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050718-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050718-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050718-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050718-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050718-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050718-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: DOXIL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXORUBICIN HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82F2G7BL4E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ee64805-1a32-49b4-a119-9376fc9e6633	Product name	5	20250305
750deab0-bb49-36cc-d493-bfaec857a32e	Product name	5	20190807
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-0067-01	DOXIL	1 in 1 CARTON	INJECTION, SUSPENSION, LIPOSOMAL	1		12
0338-0067-01	DOXIL	25 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION, LIPOSOMAL	25		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0067-01	ML - Milliliter	0338-0067	7850d4ed-63c9-422d-878b-eaf385ecfc09	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0067	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE COMPANY]	11	Current NDC, Legacy NDC, 2 package rows	20250430_1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXIL	DOXORUBICIN HYDROCHLORIDE	Baxter Healthcare Corporation	917eddf9-1d3f-4abe-8c81-d33b066e5bae	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050718 application number: NDA050718
DOXIL	DOXORUBICIN HYDROCHLORIDE	Baxter Healthcare Company	1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce	2022-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050718 application number: NDA050718 ndc (product): 0338-0067
Doxorubicin Hydrochloride Liposome	DOXORUBICIN HYDROCHLORIDE LIPOSOME	Baxter Healthcare Company	cf25a018-e795-49e4-8533-a581f8366dd9	2022-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050718 application number: NDA050718

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82F2G7BL4E	DOXORUBICIN HYDROCHLORIDE	25316-40-9	DOXORUBICIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0067-01	00338006701	1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 mL in 1 VIAL, SINGLE-USE	2019-08-13	0000-00-00	No	No	Current