Fluocinonide

Product NDC: 52565-040
Requested package NDC: 52565-040-60
11-digit product format: 525650040
Labeler code: 52565
Product ID: 52565-040_73762cba-77e3-42b5-a7cf-6c5b0bccac6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluocinonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA207680
Marketing category: ANDA
Marketing start: 2016-08-09
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	52565-040	52565-040-60	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 15 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-040	52565-040-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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
A207680-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL			2018-09-28

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	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL		2018-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207680-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	2018-09-28	`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	A207680-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207680-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207680-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207680-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207680-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207680-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207680-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207680-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207680-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207680-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207680-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207680-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207680-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207680-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207680-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207680-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207680-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207680-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207680-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207680-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207680-001	AB	1	`cb3db0bc1861…`

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
52565-040-15	2023-01-30	C162847	48780-1	f386c649-c85d-0266-e053-dadaa90a7c1a	Fluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-040-30	2023-01-30	C162847	48780-1	f386c649-c85d-0266-e053-dadaa90a7c1a	Fluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-040-60	2023-01-30	C162847	48780-1	f386c649-c85d-0266-e053-dadaa90a7c1a	Fluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-040-15	Fluocinonide	15 g in 1 TUBE	OINTMENT	15	1
52565-040-15	Fluocinonide	1 in 1 CARTON	OINTMENT	1	1
52565-040-30	Fluocinonide	1 in 1 CARTON	OINTMENT	1	1
52565-040-30	Fluocinonide	30 g in 1 TUBE	OINTMENT	30	1
52565-040-60	Fluocinonide	1 in 1 CARTON	OINTMENT	1	1
52565-040-60	Fluocinonide	60 g in 1 TUBE	OINTMENT	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-040-15	GM - Gram	52565-040	23a2d61e-d292-42b6-b98d-37deda3fc875	1	2019-01-24
52565-040-30	GM - Gram	52565-040	e7b52bd2-0edb-4eee-b945-e3acc0c0ab18	1	2019-01-24
52565-040-60	GM - Gram	52565-040	8de6593c-f388-415a-86ab-585433508d6c	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-040	FLUOCINONIDE (FLUOCINONIDE) OINTMENT [TELIGENT PHARMA, INC.]	1	Legacy NDC, 6 package rows	20181010_222eaeb1-778b-4bd6-801a-13d51eadf111.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
103457	fluocinonide 0.05 % Topical Ointment	PSN	222eaeb1-778b-4bd6-801a-13d51eadf111	1
103457	fluocinonide 0.0005 MG/MG Topical Ointment	SCD	222eaeb1-778b-4bd6-801a-13d51eadf111	1
103457	fluocinonide 0.05 % Topical Ointment	SY	222eaeb1-778b-4bd6-801a-13d51eadf111	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-040-60	52565004060	1 TUBE in 1 CARTON (52565-040-60) > 60 g in 1 TUBE	1 tube	2016-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only	Teligent Pharma, Inc.	2018-09-28	HUMAN PRESCRIPTION DRUG LABEL	1