Docetaxel

Product NDC: 42367-121
11-digit product format: 423670121
Labeler code: 42367
Product ID: 42367-121_a7c30dd3-94ef-4b69-b492-2878133f48b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: docetaxel
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Eagle Pharmaceuticals, Inc.
Application: NDA205934
Marketing category: NDA
Marketing start: 2016-01-15
Marketing end: 2019-05-12
Substance: DOCETAXEL
Active strength: 20 mg/mL
Pharmacologic classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42367-121		D	Discontinued by firm	2026-08-11
excluded package	package	42367-121	42367-121-21	D	Discontinued by firm	2026-08-11
excluded package	package	42367-121	42367-121-25	D	Discontinued by firm	2026-08-11
excluded package	package	42367-121	42367-121-29	D	Discontinued by firm	2026-08-11

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 · 48 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	42367-121-29	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42367-121-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42367-121-21	`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	42367-121-29	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42367-121-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42367-121-21	`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	42367-121-29	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42367-121-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42367-121-21	`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	42367-121-29	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42367-121-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42367-121-21	`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	42367-121-29	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42367-121-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42367-121-21	`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	42367-121-29	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42367-121-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42367-121-21	`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	42367-121-29	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42367-121-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42367-121-21	`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	42367-121-29	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42367-121-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42367-121-21	`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	42367-121-29	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42367-121-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42367-121-21	`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	42367-121-29	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42367-121-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42367-121-21	`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	42367-121-29	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42367-121-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42367-121-21	`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	42367-121-29	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42367-121-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42367-121-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205934-001	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22
N205934-002	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22
N205934-003	DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N205934-001	AP
N205934-002	AP
N205934-003	AP

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205934-001	10842770	2031-08-07	U-2998	Drug product	2020-12-15
N205934-001	8940786	2033-09-30	U-1789	Drug product	2016-01-06
N205934-001	9308195	2033-09-30		Drug product	2016-05-06
N205934-001	9763880	2033-09-30	U-2558		2019-06-28
N205934-001	9763880	2033-09-30	U-2559		2019-06-28
N205934-001	9763880	2033-09-30	U-2560		2019-06-28
N205934-001	9763880	2033-09-30	U-2561		2019-06-28
N205934-001	9763880	2033-09-30	U-2562		2019-06-28
N205934-001	9763880	2033-09-30	U-2563		2019-06-28
N205934-001	9763880	2033-09-30	U-2564		2019-06-28
N205934-002	10842770	2031-08-07	U-2998	Drug product	2020-12-15
N205934-002	8940786	2033-09-30	U-1789	Drug product	2016-01-06
N205934-002	9308195	2033-09-30		Drug product	2016-05-06
N205934-002	9763880	2033-09-30	U-2558		2019-06-28
N205934-002	9763880	2033-09-30	U-2559		2019-06-28
N205934-002	9763880	2033-09-30	U-2560		2019-06-28
N205934-002	9763880	2033-09-30	U-2561		2019-06-28
N205934-002	9763880	2033-09-30	U-2562		2019-06-28
N205934-002	9763880	2033-09-30	U-2563		2019-06-28
N205934-002	9763880	2033-09-30	U-2564		2019-06-28
N205934-003	10842770	2031-08-07	U-2998	Drug product	2020-12-15
N205934-003	8940786	2033-09-30	U-1789	Drug product	2016-01-06
N205934-003	9308195	2033-09-30		Drug product	2016-05-06
N205934-003	9763880	2033-09-30	U-2558		2019-06-28
N205934-003	9763880	2033-09-30	U-2559		2019-06-28
N205934-003	9763880	2033-09-30	U-2560		2019-06-28
N205934-003	9763880	2033-09-30	U-2561		2019-06-28
N205934-003	9763880	2033-09-30	U-2562		2019-06-28
N205934-003	9763880	2033-09-30	U-2563		2019-06-28
N205934-003	9763880	2033-09-30	U-2564		2019-06-28

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 4 · 123 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	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205934-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205934-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205934-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2015-12-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N205934-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205934-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205934-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205934-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205934-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205934-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205934-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205934-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205934-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205934-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205934-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205934-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205934-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205934-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205934-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205934-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205934-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205934-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205934-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205934-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205934-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205934-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205934-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205934-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205934-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205934-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205934-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205934-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205934-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205934-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205934-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205934-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205934-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205934-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205934-001	AP	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 31 · 1,212 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205934-001	10842770	2031-08-07	U-2998	Drug product	2020-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	8940786	2033-09-30	U-1789	Drug product	2016-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9308195	2033-09-30		Drug product	2016-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2560		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2564		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2559		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2558		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2563		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2561		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-001	9763880	2033-09-30	U-2562		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	10842770	2031-08-07	U-2998	Drug product	2020-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	8940786	2033-09-30	U-1789	Drug product	2016-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9308195	2033-09-30		Drug product	2016-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2561		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2562		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2564		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2560		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2563		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2558		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-002	9763880	2033-09-30	U-2559		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	10842770	2031-08-07	U-2998	Drug product	2020-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	8940786	2033-09-30	U-1789	Drug product	2016-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9308195	2033-09-30		Drug product	2016-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2563		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2559		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2558		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2562		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2564		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2561		2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205934-003	9763880	2033-09-30	U-2560		2019-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	10842770	2031-08-07	U-2998	Drug product	2020-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	8940786	2033-09-30	U-1789	Drug product	2016-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9308195	2033-09-30		Drug product	2016-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2560		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2564		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2559		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2558		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2563		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2561		2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205934-001	9763880	2033-09-30	U-2562		2019-06-28	`31067a03dcf5…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42367-121-21	ML - Milliliter	42367-121	90412a90-96db-49ec-bee5-b2877d3620a3	1	2016-02-04
42367-121-25	ML - Milliliter	42367-121	297757b9-8514-44ec-8081-60e0c2b2f149	1	2016-02-04
42367-121-29	ML - Milliliter	42367-121	68826e22-f6d8-450a-8edb-6daa72dfef3c	1	2016-02-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15H5577CQD	DOCETAXEL	148408-66-6	DOCETAXEL

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docetaxel Non-Alcohol Formula	Eagle Pharmaceuticals, Inc.	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	9