Fluocinonide

Product NDC: 52565-079
Requested package NDC: 52565-079-30
11-digit product format: 525650079
Labeler code: 52565
Product ID: 52565-079_285c6180-cee8-4878-9e76-e8bb321c1af8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA211758
Marketing category: ANDA
Marketing start: 2018-03-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52565-079	52565-079-30	I	Inactivated by FDA		2026-08-03

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211758-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL			2019-04-03

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	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2019-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211758-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2019-04-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211758-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211758-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211758-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211758-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211758-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211758-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211758-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211758-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211758-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211758-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211758-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211758-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211758-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211758-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211758-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211758-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211758-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211758-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211758-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211758-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211758-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
de14082b-1b4a-48ac-b75c-4ee3ff8a29be	Product name	1	20180809
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-079-11	2023-01-30	C162847	48780-1	f386c64a-133c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971
52565-079-30	2023-01-30	C162847	48780-1	f386c64a-133c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971
52565-079-60	2023-01-30	C162847	48780-1	f386c64a-133c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-079-11	Fluocinonide	120 g in 1 TUBE	CREAM	120	1
52565-079-11	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-079-30	Fluocinonide	30 g in 1 TUBE	CREAM	30	1
52565-079-30	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-079-60	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-079-60	Fluocinonide	60 g in 1 TUBE	CREAM	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-079-11	GM - Gram	52565-079	fe191fb9-8ebd-4b3c-bf1a-7d74e50fa7b5	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-079	FLUOCINONIDE CREAM [TELIGENT PHARMA, INC.]	1	Legacy NDC, 6 package rows	20190416_43770897-5784-4817-9fb1-7057b5447d5c.zip

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
485647	fluocinonide 0.1 % Topical Cream	PSN	43770897-5784-4817-9fb1-7057b5447d5c	1
485647	fluocinonide 1 MG/ML Topical Cream	SCD	43770897-5784-4817-9fb1-7057b5447d5c	1
485647	fluocinonide 0.1 % Topical Cream	SY	43770897-5784-4817-9fb1-7057b5447d5c	1
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	43770897-5784-4817-9fb1-7057b5447d5c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-079-30	52565007930	1 TUBE in 1 CARTON (52565-079-30) > 30 g in 1 TUBE	1 tube	2019-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide	Preferred Pharmaceuticals, Inc.	2021-05-07	HUMAN PRESCRIPTION DRUG LABEL	2
Fluocinonide	Quality Care Products, LLC	2020-08-06	HUMAN PRESCRIPTION DRUG LABEL	1
Fluocinonide	Teligent Pharma, Inc. \| Teligent, Inc.	2019-04-03	HUMAN PRESCRIPTION DRUG LABEL	1