Fluocinonide

Product NDC: 53002-9202
Requested package NDC: 53002-9202-1
11-digit product format: 530029202
Labeler code: 53002
Product ID: 53002-9202_28c867b0-31db-487d-8df1-cf5dad9c044a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA071500
Marketing category: ANDA
Marketing start: 2016-10-27
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-9202	53002-9202-1	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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	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
A071500-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		1987-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071500-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071500-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	1987-06-10	`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	A071500-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071500-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071500-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071500-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071500-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071500-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071500-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071500-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071500-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071500-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071500-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071500-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071500-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071500-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071500-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071500-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071500-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071500-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071500-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071500-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071500-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071500-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071500-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071500-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071500-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071500-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071500-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071500-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071500-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071500-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071500-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071500-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071500-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071500-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071500-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071500-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071500-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071500-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071500-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071500-001	AB1	1	`e64feba35796…`

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
53002-9202-1	2025-01-30	C162847	48780-1	2cef2736-6142-d83d-e063-dadaa90ab31f	Fluocinonide Cream USP, 0.05%
53002-9202-2	2025-01-30	C162847	48780-1	2cef2736-6142-d83d-e063-dadaa90ab31f	Fluocinonide Cream USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-9202-1	Fluocinonide	15 g in 1 TUBE	CREAM	15		1
53002-9202-2	Fluocinonide	15 g in 1 TUBE	CREAM	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-9202	FLUOCINONIDE CREAM [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20220331_d823803c-a125-4695-a04b-6c14b6a66ab6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	A-S Medication Solutions	a2e8aa7a-8996-4dc8-a36b-e8c29fb8540e	2025-12-06	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500
Fluocinonide	FLUOCINONIDE	Sun Pharmaceutical Industries, Inc.	5782d791-48fd-4cee-853d-235eb4d04a40	2025-07-08	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals,Inc.	8ac0ecd6-38b5-a5f9-e053-2a95a90af412	2024-06-14	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500
Fluocinonide	FLUOCINONIDE	NuCare Pharmaceuticals Inc.	624c81a7-282a-95be-e053-2991aa0a6b44	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 071500 application number: ANDA071500

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	d823803c-a125-4695-a04b-6c14b6a66ab6	1
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	d823803c-a125-4695-a04b-6c14b6a66ab6	1
103456	fluocinonide 0.05 % Topical Cream	SY	d823803c-a125-4695-a04b-6c14b6a66ab6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-9202-1	53002920201	15 g in 1 TUBE (53002-9202-1)	15 g	2021-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Cream USP, 0.05%	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1