Docetaxel

Product NDC: 66758-950
Requested package NDC: 66758-950-04
11-digit product format: 667580950
Labeler code: 66758
Product ID: 66758-950_f161a570-3193-49b4-b2e9-fee4d17404f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: docetaxel
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc.
Application: NDA201525
Marketing category: NDA
Marketing start: 2015-07-22
Marketing end: 0000-00-00
Substance: DOCETAXEL
Active strength: 10 mg/mL
Pharmacologic classes: Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66758-950	66758-950-04	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
N201525-001	DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29
N201525-002	DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29
N201525-003	DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201525-001	AP
N201525-002	AP
N201525-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2011-06-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N201525-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201525-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201525-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201525-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201525-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201525-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201525-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201525-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201525-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201525-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201525-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201525-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201525-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201525-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201525-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201525-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201525-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201525-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201525-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201525-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201525-001	AP	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66758-950-02	ML - Milliliter	66758-950	611987c8-e057-4863-a18e-243e83d34a7b	1	2015-09-10
66758-950-03	ML - Milliliter	66758-950	ae4a593b-c50e-4ece-bc89-604f8ca632e1	1	2015-09-10
66758-950-04	ML - Milliliter	66758-950	8e7d5166-85a1-4146-94ce-52dab39ab7d6	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCETAXEL	ACTIVE INGREDIENT	15H5577CQD	DOCETAXEL INJECTION, SOLUTION [SANDOZ INC]	1
DOCETAXEL ANHYDROUS	ACTIVE MOIETY	699121PHCA	DOCETAXEL INJECTION, SOLUTION [SANDOZ INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DOCETAXEL INJECTION, SOLUTION [SANDOZ INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DOCETAXEL INJECTION, SOLUTION [SANDOZ INC]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	DOCETAXEL INJECTION, SOLUTION [SANDOZ INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DOCETAXEL INJECTION, SOLUTION [SANDOZ INC]	1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Docetaxel	DOCETAXEL	Baxter Healthcare Corporation	0e0f06bd-d190-45da-be8b-062e8de01970	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201525 application number: NDA201525
Docetaxel	DOCETAXEL	Sandoz Inc.	e03d1378-6889-43d5-a34c-f96132cffa88	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201525 application number: NDA201525

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66758-950-04	66758095004	1 VIAL, MULTI-DOSE in 1 CARTON (66758-950-04) > 16 mL in 1 VIAL, MULTI-DOSE	2015-07-22	0000-00-00	No	No	Current