FLUOCINONIDE

Product NDC: 72578-087
11-digit product format: 725780087
Labeler code: 72578
Product ID: 72578-087_289f3db8-a73f-4141-8c35-5b3c53b9a16c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUOCINONIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Viona Pharmaceuticals Inc
Application: ANDA208989
Marketing category: ANDA
Marketing start: 2020-04-30
Substance: FLUOCINONIDE
Active strength: 1 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
A208989-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB		2020-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208989-001	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.

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	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a50c72e98297…`

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	A208989-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208989-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208989-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208989-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208989-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208989-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208989-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208989-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208989-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208989-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208989-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208989-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208989-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208989-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208989-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208989-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208989-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208989-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208989-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208989-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208989-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208989-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208989-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208989-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208989-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208989-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208989-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208989-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208989-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208989-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208989-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208989-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208989-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208989-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208989-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208989-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208989-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208989-001	AB	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	1 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
485647	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
248675bd-c797-46ab-adf9-f37352c33059	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
de14082b-1b4a-48ac-b75c-4ee3ff8a29be	Product name	1	20180809
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72578-087-02	FLUOCINONIDE	60 g in 1 TUBE	CREAM	60	2
72578-087-06	FLUOCINONIDE	30 g in 1 TUBE	CREAM	30	2
72578-087-07	FLUOCINONIDE	120 g in 1 TUBE	CREAM	120	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72578-087	FLUOCINONIDE CREAM [VIONA PHARMACEUTICALS INC]	2	Current NDC, Legacy NDC, 3 package rows	20221122_248675bd-c797-46ab-adf9-f37352c33059.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOCINONIDE	FLUOCINONIDE	Zydus Lifesciences Limited	08d69d3f-c628-4b08-a7ae-0f7ec5599d3a	2024-08-16		Exact identifier application applno (ANDA): 208989 application number: ANDA208989
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	3e549888-f5f9-41da-b30d-a499da852282	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	7055d0d3-b148-4ab3-b423-9fc417204b0a	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	50d06efd-9caa-4254-bf1f-eb430c5178b0	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989
FLUOCINONIDE	FLUOCINONIDE	Bryant Ranch Prepack	34b5a550-4152-4f77-bc07-e4f023fca568	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989
FLUOCINONIDE	FLUOCINONIDE	Viona Pharmaceuticals Inc	248675bd-c797-46ab-adf9-f37352c33059	2022-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208989 application number: ANDA208989 ndc (product): 72578-087

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
485647	fluocinonide 0.1 % Topical Cream	PSN	34b5a550-4152-4f77-bc07-e4f023fca568	102
485647	fluocinonide 0.1 % Topical Cream	PSN	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 0.1 % Topical Cream	PSN	50d06efd-9caa-4254-bf1f-eb430c5178b0	102
485647	fluocinonide 1 MG/ML Topical Cream	SCD	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 1 MG/ML Topical Cream	SCD	34b5a550-4152-4f77-bc07-e4f023fca568	102
485647	fluocinonide 1 MG/ML Topical Cream	SCD	50d06efd-9caa-4254-bf1f-eb430c5178b0	102
485647	fluocinonide 0.1 % Topical Cream	SY	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 0.1 % Topical Cream	SY	34b5a550-4152-4f77-bc07-e4f023fca568	102
485647	fluocinonide 0.1 % Topical Cream	SY	50d06efd-9caa-4254-bf1f-eb430c5178b0	102
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	34b5a550-4152-4f77-bc07-e4f023fca568	102
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	50d06efd-9caa-4254-bf1f-eb430c5178b0	102
485647	fluocinonide 0.1 % Topical Cream	PSN	3e549888-f5f9-41da-b30d-a499da852282	100
485647	fluocinonide 1 MG/ML Topical Cream	SCD	3e549888-f5f9-41da-b30d-a499da852282	100
485647	fluocinonide 0.1 % Topical Cream	SY	3e549888-f5f9-41da-b30d-a499da852282	100
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	3e549888-f5f9-41da-b30d-a499da852282	100
485647	fluocinonide 0.1 % Topical Cream	PSN	248675bd-c797-46ab-adf9-f37352c33059	2
485647	fluocinonide 1 MG/ML Topical Cream	SCD	248675bd-c797-46ab-adf9-f37352c33059	2
485647	fluocinonide 0.1 % Topical Cream	SY	248675bd-c797-46ab-adf9-f37352c33059	2
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	248675bd-c797-46ab-adf9-f37352c33059	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72578-087-02	72578008702	60 g in 1 TUBE (72578-087-02)	60 g	2020-04-30	0000-00-00	No	No	Current
72578-087-06	72578008706	30 g in 1 TUBE (72578-087-06)	30 g	2020-04-30	0000-00-00	No	No	Current
72578-087-07	72578008707	120 g in 1 TUBE (72578-087-07)	120 g	2020-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUOCINONIDE	Bryant Ranch Prepack	2024-02-02	HUMAN PRESCRIPTION DRUG LABEL	100
FLUOCINONIDE	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
FLUOCINONIDE	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
FLUOCINONIDE	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102
FLUOCINONIDE	Viona Pharmaceuticals Inc \| Zydus Lifesciences Limited	2022-10-04	HUMAN PRESCRIPTION DRUG LABEL	2