FLUOCINONIDE

Product NDC: 63629-2508
11-digit product format: 636292508
Labeler code: 63629
Product ID: 63629-2508_044103f1-8aa3-4d79-b0ee-acf105a841e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUOCINONIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
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
7055d0d3-b148-4ab3-b423-9fc417204b0a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2508-1	FLUOCINONIDE	120 g in 1 TUBE	CREAM	120		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2508-1	GM - Gram	63629-2508	cc6e7a2d-96a2-4fda-b125-310154f604a0	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2508	FLUOCINONIDE CREAM [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20230306_7055d0d3-b148-4ab3-b423-9fc417204b0a.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 ndc (product): 63629-2508
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

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	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 1 MG/ML Topical Cream	SCD	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 0.1 % Topical Cream	SY	7055d0d3-b148-4ab3-b423-9fc417204b0a	102
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	7055d0d3-b148-4ab3-b423-9fc417204b0a	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2508-1	63629250801	120 g in 1 TUBE (63629-2508-1)	120 g	2021-05-18	0000-00-00	No	No	Current