Paclitaxel

Product NDC: 63323-763
11-digit product format: 633230763
Labeler code: 63323
Product ID: 63323-763_11fa3178-16bd-4da3-b276-079ce8e12efb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paclitaxel
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA077574
Marketing category: ANDA
Marketing start: 2009-03-20
Substance: PACLITAXEL
Active strength: 6 mg/mL
Pharmacologic classes: Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63323-763		D	Discontinued by firm	2026-08-11
excluded product	product	63323-763		D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-05	D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-06	D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-17	D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-52	D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-06	D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-17	D	Discontinued by firm	2026-08-11
excluded package	package	63323-763	63323-763-52	D	Discontinued by firm	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 2 · 106 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-763-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-763-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-763-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-763-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-52	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-763-52	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-52	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-763-52	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-763-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-763-52	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-763-17	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-763-06	`302b2466d912…`	`e7b80fea0513…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077574-001	PACLITAXEL	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP		2006-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077574-001	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 2 · 41 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	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077574-001	PACLITAXEL	6MG/ML	INJECTABLE / INJECTION	AP	2006-11-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A077574-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077574-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077574-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077574-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077574-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077574-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077574-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077574-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077574-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077574-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077574-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077574-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077574-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077574-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077574-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077574-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077574-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077574-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077574-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077574-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077574-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077574-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077574-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077574-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077574-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077574-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077574-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077574-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077574-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077574-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077574-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077574-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077574-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077574-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077574-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077574-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077574-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077574-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077574-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077574-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PACLITAXEL	6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P88XT4IS4D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312199	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
a6c24189-293f-42ca-b969-75870bb55af0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9bfd8626-d4ce-43ae-acb3-8de37f80302f	Product name	3	20260126
2cc1dc98-28db-3a82-b37e-4e50de7c4f94	Product name	5	20240102
a05831c4-07a7-44ad-9dc5-89391450ee82	Product name	1	20230323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-763-05	Paclitaxel	1 in 1 CARTON	INJECTION, SOLUTION	1	13
63323-763-05	Paclitaxel	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	13
63323-763-16	Paclitaxel	1 in 1 CARTON	INJECTION, SOLUTION	1	13
63323-763-16	Paclitaxel	16.7 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	16.7	13
63323-763-50	Paclitaxel	1 in 1 CARTON	INJECTION, SOLUTION	1	13
63323-763-50	Paclitaxel	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-763-05	ML - Milliliter	63323-763	59314b53-1787-4052-b8e8-a21256a96372	1	2012-07-24
63323-763-06	ML - Milliliter	63323-763	60e22a79-f93f-4650-9a15-c8dd2105fa44	1	2014-10-03
63323-763-16	ML - Milliliter	63323-763	dbb678a8-81a3-4d66-8520-1e98839aa0e1	1	2012-07-24
63323-763-17	ML - Milliliter	63323-763	116ad3d0-cc78-4379-a51b-221a58a87203	1	2014-10-03
63323-763-50	ML - Milliliter	63323-763	10a35ac1-0689-45af-9592-7a332a5b43b0	1	2012-07-24
63323-763-52	ML - Milliliter	63323-763	e04966be-66d6-4c3a-9578-7d80f9f140cc	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PACLITAXEL	ACTIVE INGREDIENT	P88XT4IS4D	PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	6
PACLITAXEL	ACTIVE MOIETY	P88XT4IS4D	PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	6
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	6
PACLITAXEL	ACTIVE INGREDIENT	P88XT4IS4D	PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
PACLITAXEL	ACTIVE MOIETY	P88XT4IS4D	PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-763	PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	13	Current NDC, Legacy NDC, 6 package rows	20241025_a6c24189-293f-42ca-b969-75870bb55af0.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
Paclitaxel	PACLITAXEL	Fresenius Kabi USA, LLC	a6c24189-293f-42ca-b969-75870bb55af0	2024-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077574 application number: ANDA077574 ndc (product): 63323-763

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P88XT4IS4D	PACLITAXEL	33069-62-4	PACLITAXEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312199	PACLitaxel 6 MG/ML Injectable Solution	PSN	a6c24189-293f-42ca-b969-75870bb55af0	13
312199	paclitaxel 6 MG/ML Injectable Solution	SCD	a6c24189-293f-42ca-b969-75870bb55af0	13
312199	paclitaxel 100 MG per 16.7 ML Injectable Solution	SY	a6c24189-293f-42ca-b969-75870bb55af0	13
312199	paclitaxel 150 MG per 25 ML Injectable Solution	SY	a6c24189-293f-42ca-b969-75870bb55af0	13
312199	paclitaxel 30 MG per 5 ML Injectable Solution	SY	a6c24189-293f-42ca-b969-75870bb55af0	13
312199	paclitaxel 300 MG per 50 ML Injectable Solution	SY	a6c24189-293f-42ca-b969-75870bb55af0	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-763-05	63323076305	1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-05) > 5 mL in 1 VIAL, MULTI-DOSE	2009-03-20	0000-00-00	No	No	Current
63323-763-16	63323076316	1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) / 16.7 mL in 1 VIAL, MULTI-DOSE	2009-03-20	0000-00-00	No	No	Current
63323-763-50	63323076350	1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) / 50 mL in 1 VIAL, MULTI-DOSE	2009-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paclitaxel Injection, USP Rx only	Fresenius Kabi USA, LLC	2024-09-19	HUMAN PRESCRIPTION DRUG LABEL	13
Fresenius Kabi USA, LLC \| CIPLA LIMITED \| Fresenius Kabi Oncology Limited blanket no changes certification of product listing	Fresenius Kabi USA, LLC \| CIPLA LIMITED \| Fresenius Kabi Oncology Limited	2017-10-11	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING	1
Paclitaxel Injection USP	Fresenius Kabi USA, LLC	2014-04-21	HUMAN PRESCRIPTION DRUG LABEL	11