Fluocinonide

Product NDC: 52565-054
Requested package NDC: 52565-054-60
11-digit product format: 525650054
Labeler code: 52565
Product ID: 52565-054_531184f7-770c-46a4-9bfa-3dbf2a575aa6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: GEL
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA209030
Marketing category: ANDA
Marketing start: 2018-06-20
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	52565-054	52565-054-60	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
A209030-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB		2018-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209030-001	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	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL		2018-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209030-001	FLUOCINONIDE	0.05%	GEL / TOPICAL	AB	2018-06-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209030-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209030-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209030-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209030-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209030-001	AB	1	`fd3edfee7708…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209030-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209030-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209030-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209030-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209030-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209030-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209030-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209030-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209030-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209030-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209030-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209030-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209030-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A209030-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209030-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209030-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209030-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209030-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209030-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209030-001	AB	1	`a50c72e98297…`

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
52565-054-15	2023-01-30	C162847	48780-1	f386c64a-0cbc-0266-e053-dadaa90a7c1a	Fluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-054-30	2023-01-30	C162847	48780-1	f386c64a-0cbc-0266-e053-dadaa90a7c1a	Fluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
52565-054-60	2023-01-30	C162847	48780-1	f386c64a-0cbc-0266-e053-dadaa90a7c1a	Fluocinonide Gel 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
52565-054-15	Fluocinonide	1 in 1 CARTON	GEL	1	3
52565-054-15	Fluocinonide	15 g in 1 TUBE	GEL	15	3
52565-054-30	Fluocinonide	1 in 1 CARTON	GEL	1	3
52565-054-30	Fluocinonide	30 g in 1 TUBE	GEL	30	3
52565-054-60	Fluocinonide	60 g in 1 TUBE	GEL	60	3
52565-054-60	Fluocinonide	1 in 1 CARTON	GEL	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-054-15	GM - Gram	52565-054	cb96e935-8c91-40a2-a957-1627d7d9d14a	1	2019-02-13
52565-054-30	GM - Gram	52565-054	83ea514f-c029-499d-bc81-6c137aac2a96	1	2019-02-13
52565-054-60	GM - Gram	52565-054	c45fb5e9-57bb-47ee-921e-66f85cf5702f	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-054	FLUOCINONIDE GEL [TELIGENT PHARMA, INC.]	3	Legacy NDC, 6 package rows	20190911_2aa35781-40e0-7ce9-45fa-f97333f29085.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOCINONIDE	FLUOCINONIDE	Padagis Israel Pharmaceuticals Ltd	8e22600e-a1a2-432c-a47c-b7b99a0b1e46	2025-02-27	Adverse reactions	Exact identifier application applno (ANDA): 209030 application number: ANDA209030

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
310362	fluocinonide 0.05 % Topical Gel	PSN	2aa35781-40e0-7ce9-45fa-f97333f29085	3
310362	fluocinonide 0.0005 MG/MG Topical Gel	SCD	2aa35781-40e0-7ce9-45fa-f97333f29085	3
310362	fluocinonide 0.05 % Topical Gel	SY	2aa35781-40e0-7ce9-45fa-f97333f29085	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-054-60	52565005460	1 TUBE in 1 CARTON (52565-054-60) > 60 g in 1 TUBE	1 tube	2018-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Gel USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only	Teligent Pharma, Inc.	2018-06-20	HUMAN PRESCRIPTION DRUG LABEL	3