FLUOCINONIDE

Product NDC: 21922-064
11-digit product format: 219220064
Labeler code: 21922
Product ID: 21922-064_d17e15ec-9150-4fe3-acd1-4573300d9bf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinonide
Dosage form: CREAM
Route: TOPICAL
Labeler: Encube Ethicals, Inc.
Application: ANDA211410
Marketing category: ANDA
Marketing start: 2025-02-25
Substance: FLUOCINONIDE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A211410-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1		2018-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211410-001	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	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL	AB1	2018-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211410-001	FLUOCINONIDE	0.05%	CREAM / TOPICAL		2018-10-16	`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	A211410-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211410-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211410-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211410-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211410-001	AB1	1	`fd3edfee7708…`
2019-12-13 00:20 UTC	2019-12	A211410-001	AB1	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A211410-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211410-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211410-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211410-001	AB1	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211410-001	AB1	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: FLUOCINONIDE
Listing expiration: 2026-12-31

Active Ingredients#

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

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
103456	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
cb869315-8011-485b-8992-1d73fb27e19e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21922-064-03	FLUOCINONIDE	1 in 1 CARTON	CREAM	1	2
21922-064-03	FLUOCINONIDE	120 g in 1 TUBE	CREAM	120	2
21922-064-04	FLUOCINONIDE	1 in 1 CARTON	CREAM	1	2
21922-064-04	FLUOCINONIDE	15 g in 1 TUBE	CREAM	15	2
21922-064-05	FLUOCINONIDE	30 g in 1 TUBE	CREAM	30	2
21922-064-05	FLUOCINONIDE	1 in 1 CARTON	CREAM	1	2
21922-064-07	FLUOCINONIDE	60 g in 1 TUBE	CREAM	60	2
21922-064-07	FLUOCINONIDE	1 in 1 CARTON	CREAM	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-064-03	GM - Gram	21922-064	1dd2cdd4-1a9d-42f2-b52f-fd07be906a96	1	2025-10-14
21922-064-04	GM - Gram	21922-064	79d2112a-c115-485c-ae7b-a9753a5f033b	1	2025-10-14
21922-064-05	GM - Gram	21922-064	55fbbfe7-ce6a-47a4-8be6-ba302dd6eded	1	2025-10-14
21922-064-07	GM - Gram	21922-064	931b3985-f732-42d1-be24-d4cc37cc497f	1	2025-10-14

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOCINONIDE	FLUOCINONIDE	Encube Ethicals, Inc.	cb869315-8011-485b-8992-1d73fb27e19e	2025-09-09	Adverse reactions	Exact identifier application applno (ANDA): 211410 application number: ANDA211410 ndc (product): 21922-064

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	cb869315-8011-485b-8992-1d73fb27e19e	2
103456	fluocinonide 0.5 MG/ML Topical Cream	SCD	cb869315-8011-485b-8992-1d73fb27e19e	2
103456	fluocinonide 0.05 % Topical Cream	SY	cb869315-8011-485b-8992-1d73fb27e19e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21922-064-03	21922006403	1 TUBE in 1 CARTON (21922-064-03) / 120 g in 1 TUBE	1 tube	2025-09-17	No	No	Current
21922-064-04	21922006404	1 TUBE in 1 CARTON (21922-064-04) / 15 g in 1 TUBE	1 tube	2025-09-17	No	No	Current
21922-064-05	21922006405	1 TUBE in 1 CARTON (21922-064-05) / 30 g in 1 TUBE	1 tube	2025-02-25	No	No	Current
21922-064-07	21922006407	1 TUBE in 1 CARTON (21922-064-07) / 60 g in 1 TUBE	1 tube	2025-02-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinonide Cream USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only	Encube Ethicals, Inc. \| Encube Ethicals Private Limited	2025-09-09	HUMAN PRESCRIPTION DRUG LABEL	2