Docetaxel

Product NDC: 72485-216
11-digit product format: 724850216
Labeler code: 72485
Product ID: 72485-216_10308491-d534-4e9f-9fcc-8d8a3eda213d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Docetaxel
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA210327
Marketing category: ANDA
Marketing start: 2020-01-15
Marketing end: 0000-00-00
Substance: DOCETAXEL
Active strength: 160 mg/8mL
Pharmacologic classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	72485-216		D	Discontinued by firm		2026-10-21
excluded package	package	72485-216	72485-216-08	D	Discontinued by firm		2026-10-21

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	TE codes	Approval date
A210327-001	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16
A210327-002	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16
A210327-003	DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210327-001	AP
A210327-002	AP
A210327-003	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 · 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	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210327-002	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210327-003	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210327-001	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-05-16	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A210327-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210327-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210327-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210327-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210327-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210327-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210327-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210327-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210327-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210327-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210327-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210327-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210327-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210327-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210327-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210327-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210327-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210327-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210327-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210327-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210327-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210327-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210327-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210327-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210327-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210327-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210327-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210327-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210327-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210327-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210327-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210327-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210327-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210327-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210327-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210327-002	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210327-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210327-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210327-002	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210327-003	AP	1	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

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

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
60a22813-7270-4733-af61-30636bce9f0f	Product name	4	20180820
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
0179c4ba-fb03-4931-875d-b4f1ba528029	Product name	1	20160107
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9ff92ef8-2da9-4645-bbf8-642e7eb0d754	Product name	1	20150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72485-216-08	Docetaxel	1 in 1 CARTON	INJECTION	1		1
72485-216-08	Docetaxel	8 mL in 1 VIAL, SINGLE-USE	INJECTION	8		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-216-08	ML - Milliliter	72485-216	39655fcd-468f-4929-908f-1c7d9b5396e4	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-216	DOCETAXEL INJECTION [ARMAS PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20200119_0dd863ec-f9dc-456c-9df5-4e9210d6cbb0.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1861411	DOCEtaxel 160 MG in 8 ML Injection	PSN	0dd863ec-f9dc-456c-9df5-4e9210d6cbb0	1
1861411	8 ML docetaxel 20 MG/ML Injection	SCD	0dd863ec-f9dc-456c-9df5-4e9210d6cbb0	1
1861411	docetaxel 160 MG per 8 ML Injection	SY	0dd863ec-f9dc-456c-9df5-4e9210d6cbb0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72485-216-08	72485021608	1 VIAL, SINGLE-USE in 1 CARTON (72485-216-08) > 8 mL in 1 VIAL, SINGLE-USE	2020-01-15	0000-00-00	No	No	Current