Fluocinonide

Product NDC: 71085-004
11-digit product format: 710850004
Labeler code: 71085
Product ID: 71085-004_4df7d200-5fec-4f32-b32c-06bded188628
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: IPG PHARMACEUTICALS, INC.
Application: ANDA200734
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71085-004		D	Discontinued by firm		2026-08-17
excluded package	package	71085-004	71085-004-01	D	Discontinued by firm		2026-08-17

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71085-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71085-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A200734-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB		2014-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200734-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200734-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-07-14	`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	A200734-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200734-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200734-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200734-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200734-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200734-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200734-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200734-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200734-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200734-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200734-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200734-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200734-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200734-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200734-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200734-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200734-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200734-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200734-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200734-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200734-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200734-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200734-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200734-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200734-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200734-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200734-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200734-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200734-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200734-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200734-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200734-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200734-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200734-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200734-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200734-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200734-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200734-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200734-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200734-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71085-004-01	2025-12-29	C162847	48780-1	3b156c62-275d-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use fluocinonide cream USP, 0.1% safely and effectively. See full prescribing information for fluocinonide cream USP, 0.1%. Fluocinonide Cream USP, 0.1% For topical use Initial U.S. Approval: 1971
71085-004-01	2025-07-29	C162847	48780-1	3b156c62-275d-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use fluocinonide cream USP, 0.1% safely and effectively. See full prescribing information for fluocinonide cream USP, 0.1%. Fluocinonide Cream USP, 0.1% For topical use Initial U.S. Approval: 1971

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71085-004-01	GM - Gram	71085-004	24bda1bb-d208-4ef5-841d-c6f4eb718270	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71085-004	FLUOCINONIDE CREAM [IPG PHARMACEUTICALS, INC.]	1	Legacy NDC	20170218_5535d3a8-112b-442c-a7cc-dee553f8efc6.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	Sun Pharmaceutical Industries, Inc.	16c7d142-e695-4e33-986f-78cb37f7b387	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200734 application number: ANDA200734
Fluocinonide	FLUOCINONIDE	Asclemed USA, Inc.	cd5d8268-77ff-41c0-8699-b583e52da30c	2023-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200734 application number: ANDA200734

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
71085-004-01	71085000401	1 TUBE in 1 CARTON (71085-004-01) > 120 g in 1 TUBE	1 tube	2016-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide	IPG PHARMACEUTICALS, INC. \| Sun Pharma Canada Inc.	2025-12-24	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide	Preferred Pharmaceuticals, Inc.	2020-05-27	HUMAN PRESCRIPTION DRUG LABEL	2