Docetaxel

Product NDC: 47335-939
11-digit product format: 473350939
Labeler code: 47335
Product ID: 47335-939_9a0d7b91-4324-4e19-9cd8-eb19266e771a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Docetaxel
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA022534
Marketing category: NDA
Marketing start: 2020-11-26
Substance: DOCETAXEL ANHYDROUS
Active strength: 160 mg/8mL
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 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	RLD / RS	Approval date
N022534-001	DOCEFREZ	DOCETAXEL	20MG/VIAL	INJECTABLE / INJECTION	RLD	2011-05-03
N022534-002	DOCEFREZ	DOCETAXEL	80MG/VIAL	INJECTABLE / INJECTION	RLD	2011-05-03
N022534-003	DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION		2019-01-08
N022534-004	DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION		2019-01-08
N022534-005	DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION		2019-01-08

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	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION			2019-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-001	DOCEFREZ	20MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-002	DOCEFREZ	80MG/VIAL	INJECTABLE / INJECTION		RLD	2011-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-003	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-004	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-005	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-01-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022534-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022534-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022534-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022534-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022534-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022534-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022534-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022534-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022534-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022534-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022534-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022534-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022534-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022534-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022534-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022534-004	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022534-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022534-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022534-004	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022534-005	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022534-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022534-004	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022534-005	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022534-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022534-004	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022534-005	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022534-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022534-004	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022534-005	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022534-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022534-004	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022534-005	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022534-003	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022534-004	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022534-005	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022534-003	AP	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCETAXEL ANHYDROUS	160 mg/8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
699121PHCA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1860480	Internal RxNorm lookup
1860485	Internal RxNorm lookup
1861411	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
c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	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
47335-939-40	Docetaxel	8 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	8		6
47335-939-40	Docetaxel	1 in 1 CARTON	INJECTION, SOLUTION	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-939-40	ML - Milliliter	47335-939	6ba69c77-9ae2-46fa-a07c-332debe0acb5	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-939	DOCETAXEL INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20210205_c85b2c62-3c33-4cbc-8b79-d5e17851a1b4.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	Sun Pharmaceutical Industries, Inc.	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	2021-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022534 application number: NDA022534 ndc (product): 47335-939

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
1861411	DOCEtaxel 160 MG in 8 ML Injection	PSN	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1860480	DOCEtaxel 20 MG in 1 ML Injection	PSN	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1860485	DOCEtaxel 80 MG in 4 ML Injection	PSN	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1860480	1 ML docetaxel 20 MG/ML Injection	SCD	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1860485	4 ML docetaxel 20 MG/ML Injection	SCD	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1861411	8 ML docetaxel 20 MG/ML Injection	SCD	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1861411	docetaxel 160 MG per 8 ML Injection	SY	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1860480	docetaxel 20 MG per 1 ML Injection	SY	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6
1860485	docetaxel 80 MG per 4 ML Injection	SY	c85b2c62-3c33-4cbc-8b79-d5e17851a1b4	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-939-40	47335093940	1 VIAL, GLASS in 1 CARTON (47335-939-40) / 8 mL in 1 VIAL, GLASS	2020-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docetaxel	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2021-02-04	Human Prescription Drug Label	6