Fluocinonide

Product NDC: 21922-001
11-digit product format: 219220001
Labeler code: 21922
Product ID: 21922-001_85d64cb1-93f5-480d-b454-ca43810c8539
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluocinonide topical solution usp, 0.05%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Encube Ethicals, Inc.
Application: ANDA209699
Marketing category: ANDA
Marketing start: 2019-04-19
Substance: FLUOCINONIDE
Active strength: .5 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A209699-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT		2018-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209699-001	AT

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	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209699-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-11-29	`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	A209699-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209699-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209699-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209699-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209699-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209699-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209699-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209699-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209699-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209699-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209699-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209699-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209699-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209699-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209699-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209699-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209699-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209699-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209699-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209699-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209699-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209699-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209699-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209699-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209699-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209699-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209699-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209699-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209699-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209699-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209699-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209699-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209699-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209699-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209699-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209699-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209699-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209699-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209699-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209699-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluocinonide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINONIDE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2W4A77YPAN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310364	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4b1f775e-a7ad-4151-975e-6026296b5cea	Available on FDA.report

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
21922-001-01	2021-11-24	C162847	48780-1	ba0f9c33-4fd6-a910-e053-dadaa90a0b85	Fluocinonide Topical Solution USP, 0.05%
21922-001-01	2021-11-24	C162847	48780-1	ba0f9c33-4fd6-a910-e053-dadaa90a0b85	Fluocinonide Topical Solution USP, 0.05%
21922-001-01	2021-11-24	C162847	48780-1	ba0f9c33-4fd6-a910-e053-dadaa90a0b85	Fluocinonide Topical Solution USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21922-001-01	Fluocinonide	1 in 1 CARTON	SOLUTION	1		7
21922-001-01	Fluocinonide	60 mL in 1 BOTTLE	SOLUTION	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-001-01	ML - Milliliter	21922-001	5d6e18ff-34a9-4534-8ec8-cb32125bfbb2	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21922-001	FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20220118_4b1f775e-a7ad-4151-975e-6026296b5cea.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 TOPICAL SOLUTION USP, 0.05%	Bryant Ranch Prepack	38a36184-22b4-4e97-83e1-fdd984ef6ccb	2026-05-14	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Bryant Ranch Prepack	628bda7e-b670-4f71-bcc4-0290d67655a0	2026-04-07	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	Encube Ethicals, Inc.	4b1f775e-a7ad-4151-975e-6026296b5cea	2026-01-09	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699 ndc (product): 21922-001
Fluocinonide	FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%	NuCare Pharmaceuticals, Inc.	44840256-471b-a719-e063-6394a90a5a14	2025-11-26	Adverse reactions	Exact identifier application applno (ANDA): 209699 application number: ANDA209699

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
310364	fluocinonide 0.05 % Topical Solution	PSN	38a36184-22b4-4e97-83e1-fdd984ef6ccb	104
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	38a36184-22b4-4e97-83e1-fdd984ef6ccb	104
310364	fluocinonide 0.05 % Topical Solution	SY	38a36184-22b4-4e97-83e1-fdd984ef6ccb	104
310364	fluocinonide 0.05 % Topical Solution	PSN	628bda7e-b670-4f71-bcc4-0290d67655a0	102
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	628bda7e-b670-4f71-bcc4-0290d67655a0	102
310364	fluocinonide 0.05 % Topical Solution	SY	628bda7e-b670-4f71-bcc4-0290d67655a0	102
310364	fluocinonide 0.05 % Topical Solution	PSN	4b1f775e-a7ad-4151-975e-6026296b5cea	7
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	4b1f775e-a7ad-4151-975e-6026296b5cea	7
310364	fluocinonide 0.05 % Topical Solution	SY	4b1f775e-a7ad-4151-975e-6026296b5cea	7
310364	fluocinonide 0.05 % Topical Solution	PSN	44840256-471b-a719-e063-6394a90a5a14	1
310364	fluocinonide 0.05 % Topical Solution	PSN	f560ead8-946f-3c79-e053-2995a90a9ea2	1
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	44840256-471b-a719-e063-6394a90a5a14	1
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	f560ead8-946f-3c79-e053-2995a90a9ea2	1
310364	fluocinonide 0.05 % Topical Solution	SY	44840256-471b-a719-e063-6394a90a5a14	1
310364	fluocinonide 0.05 % Topical Solution	SY	f560ead8-946f-3c79-e053-2995a90a9ea2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21922-001-01	21922000101	1 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLE	1 bottle	2019-04-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Topical Solution USP, 0.05%	Bryant Ranch Prepack	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	104
Fluocinonide Topical Solution USP, 0.05%	Bryant Ranch Prepack	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	102
Fluocinonide Topical Solution USP, 0.05%	Encube Ethicals, Inc. \| Encube Ethicals Private Limited	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	7
Fluocinonide Topical Solution USP, 0.05%	NuCare Pharmaceuticals, Inc.	2025-11-26	HUMAN PRESCRIPTION DRUG LABEL	1
Fluocinonide Topical Solution USP, 0.05%	NuCare Pharmaceuticals,Inc.	2023-02-23	HUMAN PRESCRIPTION DRUG LABEL	1