Docetaxel anhydrous

Product NDC: 71288-151
Requested package NDC: 71288-151-96
11-digit product format: 712880151
Labeler code: 71288
Product ID: 71288-151_bde50f3a-b83d-ae1d-e053-2a95a90a3d89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Docetaxel anhydrous
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc
Application: ANDA209634
Marketing category: ANDA
Marketing start: 2018-08-24
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: 2022-12-31
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	71288-151	71288-151-96	I	Inactivated by FDA		2026-08-11

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209634-001	DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24
A209634-002	DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24
A209634-003	DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209634-001	AP
A209634-002	AP
A209634-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209634-002	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209634-003	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209634-001	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	AP	2018-08-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209634-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209634-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209634-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209634-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209634-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209634-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209634-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209634-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209634-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209634-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209634-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209634-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209634-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209634-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209634-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209634-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209634-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209634-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209634-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209634-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209634-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209634-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209634-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209634-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209634-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209634-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209634-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209634-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209634-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209634-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209634-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209634-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209634-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209634-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209634-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209634-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209634-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209634-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209634-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209634-001	AP	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71288-151-95	2023-01-30	C162847	48780-1	f386c649-c9dd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996
71288-151-96	2023-01-30	C162847	48780-1	f386c649-c9dd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71288-151-95	Docetaxel anhydrous	8 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	8	2
71288-151-95	Docetaxel anhydrous	1 in 1 CARTON	INJECTION, SOLUTION	1	2
71288-151-96	Docetaxel anhydrous	1 in 1 CARTON	INJECTION, SOLUTION	1	2
71288-151-96	Docetaxel anhydrous	16 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	16	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-151	DOCETAXEL ANHYDROUS INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC]	2	Legacy NDC, 4 package rows	20210330_9cd030b6-f98d-451e-93cb-0a998f4c6012.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 anhydrous	DOCETAXEL ANHYDROUS	Meitheal Pharmaceuticals Inc	9fb533da-a7ba-4c2b-8e4f-8e336ba55d12	2023-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209634 application number: ANDA209634

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1093280	DOCEtaxel 10 MG/ML Injectable Solution	PSN	9cd030b6-f98d-451e-93cb-0a998f4c6012	2
1860619	DOCEtaxel 20 MG in 2 ML Injection	PSN	9cd030b6-f98d-451e-93cb-0a998f4c6012	2
1860619	2 ML docetaxel 10 MG/ML Injection	SCD	9cd030b6-f98d-451e-93cb-0a998f4c6012	2
1093280	docetaxel 10 MG/ML Injectable Solution	SCD	9cd030b6-f98d-451e-93cb-0a998f4c6012	2
1860619	docetaxel 20 MG per 2 ML Injection	SY	9cd030b6-f98d-451e-93cb-0a998f4c6012	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-151-96	71288015196	1 VIAL, MULTI-DOSE in 1 CARTON (71288-151-96) > 16 mL in 1 VIAL, MULTI-DOSE	2018-08-24	0000-00-00	No	No	Current