Docetaxel

Product NDC: 16729-231
11-digit product format: 167290231
Labeler code: 16729
Product ID: 16729-231_6eb31fb5-dae4-45e1-e053-2a91aa0aa5d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Docetaxel
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Accord Healthcare Inc.
Application: NDA201195
Marketing category: NDA
Marketing start: 2012-07-01
Marketing end: 0000-00-00
Substance: DOCETAXEL ANHYDROUS
Active strength: 20 mg/mL
Pharmacologic classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	16729-231		D	Discontinued by firm	2026-08-11
excluded package	package	16729-231	16729-231-63	D	Discontinued by firm	2026-08-11
excluded package	package	16729-231	16729-231-64	D	Discontinued by firm	2026-08-11
excluded package	package	16729-231	16729-231-65	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	16729-231-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16729-231-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16729-231-64	`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	16729-231-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16729-231-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16729-231-64	`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	16729-231-65	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16729-231-63	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16729-231-64	`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	16729-231-65	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16729-231-63	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16729-231-64	`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	16729-231-65	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16729-231-63	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16729-231-64	`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	16729-231-65	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16729-231-63	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16729-231-64	`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	16729-231-65	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16729-231-63	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16729-231-64	`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	16729-231-65	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16729-231-63	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16729-231-64	`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	16729-231-65	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16729-231-63	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16729-231-64	`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	16729-231-65	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16729-231-63	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16729-231-64	`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	16729-231-65	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16729-231-63	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16729-231-64	`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	16729-231-65	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16729-231-63	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16729-231-64	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201195-001	DOCETAXEL	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08
N201195-002	DOCETAXEL	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08
N201195-003	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20
N201195-004	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20
N201195-005	DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201195-003	AP
N201195-004	AP
N201195-005	AP

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 6 · 205 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	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-001	DOCETAXEL	20MG/0.5ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-002	DOCETAXEL	80MG/2ML (40MG/ML)	INJECTABLE / INJECTION		RLD	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD	2012-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-04-20	`5bbf6a4d5a75…`

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	N201195-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201195-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201195-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201195-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201195-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201195-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201195-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201195-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201195-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201195-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201195-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201195-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201195-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201195-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201195-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201195-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201195-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201195-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201195-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201195-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201195-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201195-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201195-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201195-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201195-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201195-004	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201195-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201195-003	AP	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be52172d-e80b-4aac-aa81-254100bce67f	Product name	9	20260304
c4fcacbc-a699-410c-905b-642c4d134e72	Product name	1	20250616
ad3381c5-7539-4a18-83b7-e7382b118d04	Product name	1	20231117
60a22813-7270-4733-af61-30636bce9f0f	Product name	4	20180820
0179c4ba-fb03-4931-875d-b4f1ba528029	Product name	1	20160107
9ff92ef8-2da9-4645-bbf8-642e7eb0d754	Product name	1	20150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-231-63	DOCETAXEL	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	20
16729-231-63	DOCETAXEL	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	1	20
16729-231-64	DOCETAXEL	4 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	4	20
16729-231-64	DOCETAXEL	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	20
16729-231-65	DOCETAXEL	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	20
16729-231-65	DOCETAXEL	8 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	8	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-231-63	ML - Milliliter	16729-231	3c171082-4d27-4103-931a-75a1dba1d95d	1	2013-02-13
16729-231-64	ML - Milliliter	16729-231	c14f8600-b86e-439d-8a0d-841b033ef119	1	2013-02-13
16729-231-65	ML - Milliliter	16729-231	da308e77-3863-490f-8778-f79a7305fd16	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCETAXEL	ACTIVE INGREDIENT	15H5577CQD	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10
DOCETAXEL ANHYDROUS	ACTIVE MOIETY	699121PHCA	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-231	DOCETAXEL INJECTION, SOLUTION, CONCENTRATE DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACCORD HEALTHCARE INC.]	20	Legacy NDC, 6 package rows	20240816_f59f7811-70b7-4c44-99f7-4f4fdce3ed22.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOCETAXEL	DOCETAXEL	Accord Healthcare Inc.	f59f7811-70b7-4c44-99f7-4f4fdce3ed22	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201195 application number: NDA201195 ndc (product): 16729-231

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
699121PHCA	DOCETAXEL ANHYDROUS	114977-28-5	DOCETAXEL ANHYDROUS
15H5577CQD	DOCETAXEL	148408-66-6	Docetaxel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1001405	DOCEtaxel 20 MG/ML Injectable Solution	PSN	f59f7811-70b7-4c44-99f7-4f4fdce3ed22	20
1001405	docetaxel 20 MG/ML Injectable Solution	SCD	f59f7811-70b7-4c44-99f7-4f4fdce3ed22	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
16729-231-63	16729023163	1 in 1 CARTON		Historical
16729-231-64	16729023164	4 mL in 1 VIAL, SINGLE-DOSE	4 ml	Historical
16729-231-65	16729023165	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOCETAXEL	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	20