Fluocinonide

Product NDC: 68462-505
11-digit product format: 684620505
Labeler code: 68462
Product ID: 68462-505_64f359f3-ab89-433a-9718-16a3c580c04f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA091282
Marketing category: ANDA
Marketing start: 2014-07-14
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: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68462-505		D	Discontinued by firm	2026-10-30
excluded package	package	68462-505	68462-505-35	D	Discontinued by firm	2026-10-30
excluded package	package	68462-505	68462-505-65	D	Discontinued by firm	2026-10-30
excluded package	package	68462-505	68462-505-66	D	Discontinued by firm	2026-10-30

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091282-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL			2014-07-14

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 · 44 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
2026-10-15 13:18:30	2026-09	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-07-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091282-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A091282-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091282-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091282-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091282-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091282-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091282-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091282-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091282-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091282-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091282-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091282-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091282-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091282-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091282-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091282-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091282-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091282-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091282-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091282-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091282-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091282-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091282-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091282-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091282-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091282-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091282-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091282-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091282-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091282-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091282-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091282-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091282-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091282-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091282-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091282-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091282-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091282-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091282-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	SPL version
68462-505-35	Fluocinonide	30 g in 1 TUBE	CREAM	30	6
68462-505-65	Fluocinonide	60 g in 1 TUBE	CREAM	60	6
68462-505-66	Fluocinonide	120 g in 1 TUBE	CREAM	120	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-505-35	GM - Gram	68462-505	739b842c-7563-48c8-927f-d13088e84b7f	1	2014-08-01
68462-505-65	GM - Gram	68462-505	097a0bd1-7f30-4bef-9f87-435d8d37b41c	1	2014-08-01
68462-505-66	GM - Gram	68462-505	26b6312b-e25c-45d3-a2a1-4e9df6806dc3	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOCINONIDE	ACTIVE INGREDIENT	2W4A77YPAN	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
FLUOCINONIDE	ACTIVE MOIETY	2W4A77YPAN	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
CETEARETH-100	INACTIVE INGREDIENT	DK070R75PW	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
DIISOPROPANOLAMINE	INACTIVE INGREDIENT	0W44HYL8T5	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-505	FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA]	6	Legacy NDC, 3 package rows	20240104_50f1c216-78c6-4b93-b732-b3beeb78bd62.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
485647	fluocinonide 0.1 % Topical Cream	PSN	50f1c216-78c6-4b93-b732-b3beeb78bd62	6
485647	fluocinonide 1 MG/ML Topical Cream	SCD	50f1c216-78c6-4b93-b732-b3beeb78bd62	6
485647	fluocinonide 0.1 % Topical Cream	SY	50f1c216-78c6-4b93-b732-b3beeb78bd62	6
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	50f1c216-78c6-4b93-b732-b3beeb78bd62	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-505-35	68462050535	30 g in 1 TUBE (68462-505-35)	30 g	2014-07-14	0000-00-00	No	No	Current
68462-505-65	68462050565	60 g in 1 TUBE (68462-505-65)	60 g	2014-07-14	0000-00-00	No	No	Current
68462-505-66	68462050566	120 g in 1 TUBE (68462-505-66)	120 g	2014-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide	Preferred Pharmaceuticals, Inc.	2020-05-27	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL	6