Fluocinonide Cream

Product NDC: 68788-8105
11-digit product format: 687888105
Labeler code: 68788
Product ID: 68788-8105_5e7e2acb-f352-479c-9334-7cc95666f3c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA210554
Marketing category: ANDA
Marketing start: 2021-11-03
Marketing end: 0000-00-00
Substance: FLUOCINONIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-8105		D	Discontinued by firm		2026-08-17
excluded package	package	68788-8105	68788-8105-3	D	Discontinued by firm		2026-08-17

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
A210554-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210554-001	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 · 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	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL			2018-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	RS	2018-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210554-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-08-21	`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	A210554-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210554-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210554-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210554-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210554-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210554-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210554-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210554-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210554-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210554-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210554-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210554-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210554-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210554-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210554-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210554-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210554-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210554-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210554-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210554-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210554-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210554-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210554-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210554-001	AB1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210554-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210554-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210554-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210554-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210554-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210554-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210554-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210554-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210554-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210554-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210554-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210554-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210554-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210554-001	AB1	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8105-3	GM - Gram	68788-8105	99102765-d5f2-40ae-b972-1708d017d3e0	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8105	FLUOCINONIDE CREAM (FLUOCINONIDE) CREAM [PREFERRED PHARMACEUTICALS INC.]	5	Legacy NDC	20250515_33601219-6ffc-4cc3-b911-fe85a5555f90.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	ab79df76-192b-422e-8d2c-dd5a46ffb216	2026-03-06	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	b1b4a6e9-814e-41e9-9f35-8bed7595265b	2026-02-08	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554
Fluocinonide Cream	FLUOCINONIDE	Amneal Pharmaceuticals NY LLC	817cac6b-fec5-406d-aa0c-8852d08a3c65	2023-06-06	Adverse reactions	Exact identifier application applno (ANDA): 210554 application number: ANDA210554

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2W4A77YPAN	FLUOCINONIDE	356-12-7	FLUOCINONIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8105-3	68788810503	1 TUBE in 1 CARTON (68788-8105-3) > 30 g in 1 TUBE	1 tube	2021-11-03	0000-00-00	No	No	Current