TOLAK

Product NDC: 64370-421
11-digit product format: 643700421
Labeler code: 64370
Product ID: 64370-421_96366719-4060-7b9d-e053-2995a90ad7b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUOROURACIL
Dosage form: CREAM
Route: TOPICAL
Labeler: Pierre Fabre Pharmaceuticals, Inc.
Application: NDA022259
Marketing category: NDA
Marketing start: 2017-03-15
Marketing end: 2020-12-31
Substance: FLUOROURACIL
Active strength: 40 mg/g
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64370-421		D	Discontinued by firm	2026-08-07
excluded package	package	64370-421	64370-421-40	D	Discontinued by firm	2026-08-07
excluded package	package	64370-421	64370-421-83	D	Discontinued by firm	2026-08-07

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 · 36 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 package	package	64370-421-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64370-421-40	`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 package	package	64370-421-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64370-421-40	`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 package	package	64370-421-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64370-421-40	`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 package	package	64370-421-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64370-421-40	`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 package	package	64370-421-83	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64370-421-40	`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 package	package	64370-421-83	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64370-421-40	`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 package	package	64370-421-83	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64370-421-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64370-421-83	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64370-421-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64370-421-83	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64370-421-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64370-421-83	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64370-421-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64370-421-83	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64370-421-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64370-421-83	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64370-421-40	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N022259-001	TOLAK	FLUOROURACIL	4%	CREAM / TOPICAL		RLD, RS	2015-09-18

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022259-001	TOLAK	4%	CREAM / TOPICAL	RLD, RS	2015-09-18	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022259-001	7169401	2023-07-18	Drug product	2015-11-04	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64370-421-40	GM - Gram	64370-421	257e6bd6-cfed-45d4-b70d-5f40440b786c	1	2017-12-14

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
TOLAK	FLUOROURACIL	HILL DERMACEUTICALS, INC.	59de2709-00b8-4f0a-867c-f0dfeb947192	2022-09-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022259 application number: NDA022259