Fluocinonide

Product NDC: 50090-1671
11-digit product format: 500901671
Labeler code: 50090
Product ID: 50090-1671_22952813-7ab3-47ca-95c1-8c90d5416635
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: A-S Medication Solutions
Application: ANDA072488
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: FLUOCINONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-1671		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-1671	50090-1671-0	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 · 30 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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`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	50090-1671-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1671-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1671-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1671-0	`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
A072488-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		1989-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072488-001	AB1

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	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072488-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1989-02-06	`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	A072488-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072488-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072488-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072488-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072488-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072488-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072488-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072488-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072488-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072488-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072488-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072488-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072488-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072488-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072488-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072488-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072488-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072488-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072488-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072488-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072488-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072488-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072488-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072488-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072488-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072488-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072488-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072488-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072488-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072488-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072488-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072488-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072488-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072488-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072488-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072488-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072488-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072488-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072488-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072488-001	AB1	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a338afdd-91bc-4c45-5113-8b445b8e6cf2	Product name	5	20200618
f3bf4e6e-291f-4372-8e90-b4047949153a	Product name	3	20200514
934e8c63-e34a-6dfb-4224-efad2d76fafc	Product name	5	20190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfe	Product name	1	20181219
ef1d202f-16bf-4f17-a390-087db27f5314	Product name	1	20181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29be	Product name	1	20180809

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1671-0	2023-01-30	C162847	48780-1	f386c64a-0693-0266-e053-dadaa90a7c1a	FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1671-0	Fluocinonide	60 g in 1 TUBE	CREAM	60		2
50090-1671-0	Fluocinonide	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1671	FLUOCINONIDE CREAM [A-S MEDICATION SOLUTIONS]	2	Legacy NDC, 2 package rows	20191001_aeb31b41-4304-427d-a78c-10f7d2e98316.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ce75f0e1-c536-40ad-b77f-2e3ec29caeb7	2024-11-06	Adverse reactions	Exact identifier application applno (ANDA): 072488 application number: ANDA072488
Fluocinonide	FLUOCINONIDE	Teva Pharmaceuticals USA, Inc.	986c1ba3-2103-4773-a35c-2c0121a01783	2024-09-30	Adverse reactions	Exact identifier application applno (ANDA): 072488 application number: ANDA072488
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals, Inc.	51cbe73c-e5d6-1e6a-e054-00144ff88e88	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 072488 application number: ANDA072488

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2W4A77YPAN	FLUOCINONIDE	356-12-7	FLUOCINONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
103456	fluocinonide 0.05 % Topical Cream	PSN	aeb31b41-4304-427d-a78c-10f7d2e98316	2
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	aeb31b41-4304-427d-a78c-10f7d2e98316	2
103456	fluocinonide 0.05 % Topical Cream	SY	aeb31b41-4304-427d-a78c-10f7d2e98316	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1671-0	50090167100	1 TUBE in 1 CARTON (50090-1671-0) > 60 g in 1 TUBE	1 tube	2015-01-28	0000-00-00	No	No	Current