Fluorouracil

Product NDC: 50090-4264
Requested package NDC: 50090-4264-0
11-digit product format: 500904264
Labeler code: 50090
Product ID: 50090-4264_6982da69-985f-4b32-bb1c-bf6d1d4ed919
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorouracil
Dosage form: CREAM
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA090368
Marketing category: ANDA
Marketing start: 2010-03-05
Marketing end: 0000-00-00
Substance: FLUOROURACIL
Active strength: 50 mg/g
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic 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	50090-4264	50090-4264-0	I	Inactivated by FDA		2026-08-17

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 42.

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
A090368-001	FLUOROURACIL	FLUOROURACIL	5%	CREAM / TOPICAL	AB		2010-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090368-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090368-001	FLUOROURACIL	5%	CREAM / TOPICAL	AB	2010-03-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090368-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090368-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090368-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090368-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090368-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090368-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090368-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090368-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090368-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090368-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090368-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090368-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090368-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090368-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090368-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090368-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090368-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090368-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090368-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090368-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090368-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090368-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090368-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090368-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090368-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090368-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090368-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090368-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090368-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090368-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090368-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090368-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090368-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090368-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090368-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090368-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090368-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090368-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090368-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090368-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dc9482d-9b87-4471-9708-4f1b4585846b	Product name	2	20250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb	Product name	5	20250630
dc0d2364-4811-4665-a3ee-7ed8c7301465	Product name	2	20171219
62fb8671-1693-49d8-8aab-0c1bfdd6794e	Product name	1	20151005
878ca466-81fd-9d24-1349-31baf36065c6	Product name	2	20150506
630d1bc2-ae6b-fd31-1264-c4733e788193	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4264-0	2023-01-30	C162847	48780-1	f386c649-a1c6-0266-e053-dadaa90a7c1a	Fluorouracil Topical Cream USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4264-0	Fluorouracil	40 g in 1 TUBE	CREAM	40		5
50090-4264-0	Fluorouracil	1 in 1 CARTON	CREAM	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4264-0	GM - Gram	50090-4264	ff8e2bb5-7a64-42a5-bc90-6299586a6194	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4264	FLUOROURACIL CREAM [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 2 package rows	20210617_ef67a3ae-144e-46db-836e-905e16e6d4c2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluorouracil	FLUOROURACIL	Sun Pharmaceutical Industries, Inc.	acca0036-f19c-459b-9dfc-9592f1cd588d	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090368 application number: ANDA090368
Fluorouracil	FLUOROURACIL	NORTHSTAR RX LLC	52ef5f41-2312-4b55-aa86-abd5bb28b9d3	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090368 application number: ANDA090368

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105583	fluorouracil 5 % Topical Cream	PSN	ef67a3ae-144e-46db-836e-905e16e6d4c2	5
105583	fluorouracil 50 MG/ML Topical Cream	SCD	ef67a3ae-144e-46db-836e-905e16e6d4c2	5
105583	5-5-fluorouracil 50 MG/ML Topical Cream	SY	ef67a3ae-144e-46db-836e-905e16e6d4c2	5
105583	5-FU 50 MG/ML Topical Cream	SY	ef67a3ae-144e-46db-836e-905e16e6d4c2	5
105583	fluorouracil 5 % Topical Cream	SY	ef67a3ae-144e-46db-836e-905e16e6d4c2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4264-0	50090426400	1 TUBE in 1 CARTON (50090-4264-0) > 40 g in 1 TUBE	1 tube	2019-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluorouracil Topical Cream USP, 5%	A-S Medication Solutions	2021-06-16	HUMAN PRESCRIPTION DRUG LABEL	5