Fluocinonide

Product NDC: 52565-029
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#

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52565-029		I	Inactivated by FDA	2026-08-03
excluded package	package	52565-029	52565-029-11	I	Inactivated by FDA	2026-08-03
excluded package	package	52565-029	52565-029-15	I	Inactivated by FDA	2026-08-03
excluded package	package	52565-029	52565-029-30	I	Inactivated by FDA	2026-08-03
excluded package	package	52565-029	52565-029-60	I	Inactivated by FDA	2026-08-03

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-029-11	2022-01-28	C162847	48780-1	d6a99b39-8349-a426-e053-dadaa90af4c2	Fluocinonide Cream USP, 0.05%
52565-029-15	2022-01-28	C162847	48780-1	d6a99b39-8349-a426-e053-dadaa90af4c2	Fluocinonide Cream USP, 0.05%
52565-029-30	2022-01-28	C162847	48780-1	d6a99b39-8349-a426-e053-dadaa90af4c2	Fluocinonide Cream USP, 0.05%
52565-029-60	2022-01-28	C162847	48780-1	d6a99b39-8349-a426-e053-dadaa90af4c2	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

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
52565-029-11	52565002911	1 TUBE in 1 CARTON (52565-029-11) > 120 g in 1 TUBE	1 tube	2018-10-16	0000-00-00	No	No	Current
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
52565-029-30	52565002930	1 TUBE in 1 CARTON (52565-029-30) > 30 g in 1 TUBE	1 tube	2018-10-16	0000-00-00	No	No	Current
52565-029-60	52565002960	1 TUBE in 1 CARTON (52565-029-60) > 60 g in 1 TUBE	1 tube	2018-10-16	0000-00-00	No	No	Current