Fluocinonide Cream

Product NDC: 68071-2667
11-digit product format: 680712667
Labeler code: 68071
Product ID: 68071-2667_db86f8ff-6977-7ce2-e053-2995a90ae128
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmceuticals,Inc.
Application: ANDA210554
Marketing category: ANDA
Marketing start: 2017-10-01
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	68071-2667		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2667	68071-2667-5	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2667-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2667-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2667-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2667-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2667-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2667-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2667-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2667-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2667-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 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
68071-2667-5	2025-01-30	C162847	48780-1	2cef2736-6e04-d83d-e063-dadaa90ab31f	Fluocinonide Cream USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2667-5	Fluocinonide Cream	30 g in 1 TUBE	CREAM	30		1
68071-2667-5	Fluocinonide Cream	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2667	FLUOCINONIDE CREAM (FLUOCINONIDE) CREAM [NUCARE PHARMCEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220401_db86f8bd-1537-f6dd-e053-2a95a90a672e.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
103456	fluocinonide 0.05 % Topical Cream	PSN	db86f8bd-1537-f6dd-e053-2a95a90a672e	1
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	db86f8bd-1537-f6dd-e053-2a95a90a672e	1
103456	fluocinonide 0.05 % Topical Cream	SY	db86f8bd-1537-f6dd-e053-2a95a90a672e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2667-5	68071266705	1 TUBE in 1 CARTON (68071-2667-5) > 30 g in 1 TUBE	1 tube	2022-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Cream	NuCare Pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2022-03-31	HUMAN PRESCRIPTION DRUG LABEL	1