Docetaxel

Product NDC: 0409-0366
11-digit product format: 004090366
Labeler code: 0409
Product ID: 0409-0366_297f1202-b539-41ee-bf52-4b9b04dd3a60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOCETAXEL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA022234
Marketing category: NDA
Marketing start: 2016-08-24
Substance: DOCETAXEL
Active strength: 20 mg/mL
Pharmacologic classes: Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022234-001	DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08
N022234-002	DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08
N022234-003	DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08
N022234-004	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23
N022234-005	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23
N022234-006	DOCETAXEL	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23
N022234-007	DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2017-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022234-001	AP
N022234-002	AP
N022234-003	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 8 · 301 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
2026-09-14 22:38:34	2026-08	N022234-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022234-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022234-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022234-004	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022234-005	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022234-006	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022234-007	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2017-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022234-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022234-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022234-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022234-004	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022234-005	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022234-006	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022234-007	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2017-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022234-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022234-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022234-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022234-004	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022234-005	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022234-006	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022234-007	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2017-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-004	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-005	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-006	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022234-007	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2017-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022234-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022234-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022234-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022234-004	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022234-005	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022234-006	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022234-007	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2017-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022234-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022234-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022234-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022234-004	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022234-005	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		RLD	2016-06-23	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022234-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022234-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022234-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022234-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022234-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022234-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022234-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022234-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022234-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022234-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022234-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022234-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022234-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022234-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022234-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022234-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022234-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022234-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022234-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022234-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022234-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022234-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022234-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022234-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022234-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022234-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022234-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022234-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022234-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022234-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022234-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022234-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022234-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022234-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022234-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022234-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022234-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022234-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022234-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022234-002	AP	1	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Docetaxel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCETAXEL	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15H5577CQD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1001405	Internal RxNorm lookup
1860480	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	Available on FDA.report

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	Strength	SPL version
0409-0366-01	Docetaxel	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		24
0409-0366-01	Docetaxel	1 in 1 CARTON	INJECTION, SOLUTION	1		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-0366-01	ML - Milliliter	0409-0366	2dfb14c0-1f30-422d-a843-73efa502cbc2	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-0366	DOCETAXEL INJECTION, SOLUTION [HOSPIRA, INC.]	24	Current NDC, Legacy NDC, 2 package rows	20241025_3104aab1-cd6e-4ad2-8e0a-286a0c5d1940.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Docetaxel	DOCETAXEL	Hospira, Inc.	6b9999bb-869e-4d25-838c-23c3ab280044	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022234 application number: NDA022234
Docetaxel	DOCETAXEL ANHYDROUS	Hospira, Inc.	644c5035-20d2-4686-beaa-bef08e99051c	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022234 application number: NDA022234
Docetaxel	DOCETAXEL ANHYDROUS	Hospira, Inc.	00c61d11-d6b7-4618-b6f6-2592dbcc8af7	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022234 application number: NDA022234
Docetaxel	DOCETAXEL	Hospira, Inc.	3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	2024-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022234 application number: NDA022234 ndc (product): 0409-0366
Docetaxel	DOCETAXEL ANHYDROUS	Hospira, Inc.	a0ec4bcc-93ea-4c41-a4b6-95ec19491807	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022234 application number: NDA022234

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
1860480	DOCEtaxel 20 MG in 1 ML Injection	PSN	3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	24
1001405	DOCEtaxel 20 MG/ML Injectable Solution	PSN	3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	24
1860480	1 ML docetaxel 20 MG/ML Injection	SCD	3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	24
1001405	docetaxel 20 MG/ML Injectable Solution	SCD	3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	24
1860480	docetaxel 20 MG per 1 ML Injection	SY	3104aab1-cd6e-4ad2-8e0a-286a0c5d1940	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-0366-01	00409036601	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0366-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2016-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docetaxel	Hospira, Inc. \| Zydus Hospira Oncology Private Limited	2024-09-19	HUMAN PRESCRIPTION DRUG LABEL	24