DOXIL

Product NDC: 59676-960
11-digit product format: 596760960
Labeler code: 59676
Product ID: 59676-960_e16858de-02ee-460c-9c14-61b6c3627940
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxorubicin hydrochloride
Dosage form: INJECTION, SUSPENSION, LIPOSOMAL
Route: INTRAVENOUS
Labeler: Janssen Products, LP
Application: NDA050718
Marketing category: NDA
Marketing start: 1995-11-17
Marketing end: 2020-09-30
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59676-960		D	Discontinued by firm	2026-08-03
excluded package	package	59676-960	59676-960-01	D	Discontinued by firm	2026-08-03
excluded package	package	59676-960	59676-960-02	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59676-960-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59676-960-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59676-960-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59676-960-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59676-960-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59676-960-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59676-960-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59676-960-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59676-960-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59676-960-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59676-960-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59676-960-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59676-960-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59676-960-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59676-960-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59676-960-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59676-960-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59676-960-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59676-960-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59676-960-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59676-960-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59676-960-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59676-960-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59676-960-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	N050718-001	DOXIL (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	1995-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050718-002	DOXIL (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD	2000-06-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	N050718-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050718-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-960-01	ML - Milliliter	59676-960	d5ce38dd-8a9c-4971-bdaa-2d7d6f705af0	1	2012-07-24
59676-960-02	ML - Milliliter	59676-960	eb2feab9-9739-463d-8f3c-17e02bb60ff2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
doxorubicin hydrochloride	ACTIVE INGREDIENT	82F2G7BL4E	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
doxorubicin	ACTIVE MOIETY	80168379AG	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
ammonium sulfate	INACTIVE INGREDIENT	SU46BAM238	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
histidine	INACTIVE INGREDIENT	4QD397987E	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
hydrogenated soybean lecithin	INACTIVE INGREDIENT	H1109Z9J4N	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT	INACTIVE INGREDIENT	3L6NN8ZZKU	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15
sucrose	INACTIVE INGREDIENT	C151H8M554	DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [JANSSEN PRODUCTS, LP]	15

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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXIL	Janssen Products, LP \| Meiji Seika Pharma Co., Ltd. \| TTY Biopharm Company Limited (Chung-Li Factory) \| GlaxoSmithKline \| Janssen Pharmaceutica NV	2019-08-16	HUMAN PRESCRIPTION DRUG LABEL	24