Fluocinonide

Product NDC: 52565-029
Requested package NDC: 52565-029-15
11-digit product format: 525650029
Labeler code: 52565
Product ID: 52565-029_f032f8fd-f723-4b97-8756-73d6eec936fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA211410
Marketing category: ANDA
Marketing start: 2018-10-16
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	52565-029	52565-029-15	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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A211410-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211410-001	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 · 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	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211410-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211410-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211410-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211410-001	AB1	1	`fd3edfee7708…`
2019-12-13 00:20 UTC	2019-12	A211410-001	AB1	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A211410-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211410-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211410-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211410-001	AB1	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211410-001	AB1	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2	Product name	5	20200618
f3bf4e6e-291f-4372-8e90-b4047949153a	Product name	3	20200514
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52565-029-11	Fluocinonide Cream USP, 0.05%
52565-029-15	Fluocinonide Cream USP, 0.05%
52565-029-30	Fluocinonide Cream USP, 0.05%
52565-029-60	Fluocinonide Cream USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-029-11	Fluocinonide	120 g in 1 TUBE	CREAM	120	1
52565-029-11	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-029-15	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-029-15	Fluocinonide	15 g in 1 TUBE	CREAM	15	1
52565-029-30	Fluocinonide	30 g in 1 TUBE	CREAM	30	1
52565-029-30	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-029-60	Fluocinonide	1 in 1 CARTON	CREAM	1	1
52565-029-60	Fluocinonide	60 g in 1 TUBE	CREAM	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-029	FLUOCINONIDE CREAM [TELIGENT PHARMA, INC.]	1	Legacy NDC, 8 package rows	20181018_22c63641-b0cf-4064-9182-8481f746edf3.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	Encube Ethicals, Inc.	cb869315-8011-485b-8992-1d73fb27e19e	2025-09-09	Adverse reactions	Exact identifier application applno (ANDA): 211410 application number: ANDA211410

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	22c63641-b0cf-4064-9182-8481f746edf3	1
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	22c63641-b0cf-4064-9182-8481f746edf3	1
103456	fluocinonide 0.05 % Topical Cream	SY	22c63641-b0cf-4064-9182-8481f746edf3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-029-15	52565002915	1 TUBE in 1 CARTON (52565-029-15) > 15 g in 1 TUBE	1 tube	2018-10-16	0000-00-00	No	No	Current