Fluocinonide

Product NDC: 68788-8554
11-digit product format: 687888554
Labeler code: 68788
Product ID: 68788-8554_39276733-703f-4d70-95ba-ddba22abb08d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA075008
Marketing category: ANDA
Marketing start: 2023-11-20
Substance: FLUOCINONIDE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A075008-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075008-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075008-001	FLUOCINONIDE	0.05%	OINTMENT / TOPICAL	AB	RS	1999-06-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075008-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075008-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075008-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075008-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075008-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075008-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075008-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075008-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075008-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075008-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075008-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075008-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075008-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075008-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075008-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075008-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075008-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075008-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075008-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075008-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075008-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075008-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075008-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075008-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075008-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075008-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075008-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075008-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075008-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075008-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075008-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075008-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075008-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075008-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075008-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075008-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075008-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075008-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075008-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075008-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluocinonide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINONIDE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2W4A77YPAN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
103457	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8554-6	Fluocinonide	1 in 1 CARTON	OINTMENT	1		4
68788-8554-6	Fluocinonide	60 g in 1 TUBE	OINTMENT	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8554-6	GM - Gram	68788-8554	7d8bb8c8-2246-4510-b8c8-26af9e62e630	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8554	FLUOCINONIDE OINTMENT [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20250515_80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Preferred Pharmaceuticals Inc.	80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	2026-04-17	Adverse reactions	Exact identifier application applno (ANDA): 075008 application number: ANDA075008 ndc (product): 68788-8554
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	b0bc89a9-c9d5-4adb-9785-2d4487c4c656	2025-12-23	Adverse reactions	Exact identifier application applno (ANDA): 075008 application number: ANDA075008

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	80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	4
103457	fluocinonide 0.0005 MG/MG Topical Ointment	SCD	80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	4
103457	fluocinonide 0.05 % Topical Ointment	SY	80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8554-6	68788855406	1 TUBE in 1 CARTON (68788-8554-6) / 60 g in 1 TUBE	1 tube	2023-11-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Cream USP, 0.05% Fluocinonide Cream USP, 0.05% (Emulsified Base) Fluocinonide Gel USP, 0.05% Fluocinonide Ointment USP, 0.05%	Preferred Pharmaceuticals Inc.	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	4