DOCETAXEL

Product NDC: 50742-463
11-digit product format: 507420463
Labeler code: 50742
Product ID: 50742-463_4e07912c-8e9d-41c3-9408-d2e5dd9d5e7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOCETAXEL ANHYDROUS
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA207563
Marketing category: ANDA
Marketing start: 2017-09-07
Marketing end: 0000-00-00
Substance: DOCETAXEL ANHYDROUS
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50742-463		D	Discontinued by firm		2026-10-23
excluded package	package	50742-463	50742-463-16	D	Discontinued by firm		2026-10-23

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A207563-001	DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2017-08-31
A207563-002	DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	2017-08-31
A207563-003	DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	2017-08-31

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 · 132 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
2026-10-15 13:18:30	2026-09	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207563-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207563-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207563-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		2017-08-31	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A207563-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207563-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207563-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207563-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207563-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207563-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207563-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207563-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207563-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207563-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207563-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207563-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207563-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207563-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207563-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207563-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207563-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207563-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207563-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207563-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207563-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207563-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207563-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207563-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207563-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207563-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207563-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207563-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207563-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207563-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207563-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207563-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207563-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207563-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207563-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207563-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207563-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207563-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207563-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207563-003	AP	1	`3bdfa0b2c4d7…`

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
50742-463-16	ML - Milliliter	50742-463	c1deacf9-aea8-4349-aeca-55d5c0dd50cf	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-463	DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION, SOLUTION [INGENUS PHARMACEUTICALS, LLC]	13	Legacy NDC	20240201_b17679e8-88c8-4b8d-bfae-246fab6eead9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
699121PHCA	DOCETAXEL ANHYDROUS	114977-28-5	DOCETAXEL ANHYDROUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-463-16	50742046316	1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16) > 16 mL in 1 VIAL, MULTI-DOSE	2017-09-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOCETAXEL	Ingenus Pharmaceuticals, LLC \| Ingenus Pharmaceuticals GmbH	2024-01-29	HUMAN PRESCRIPTION DRUG LABEL	13