Fluocinolone acetonide

Product NDC: 45802-485
Requested package NDC: 45802-485-26
11-digit product format: 458020485
Labeler code: 45802
Product ID: 45802-485_a42dc988-a62b-4c68-8736-f4a363ab4b35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone acetonide
Dosage form: OIL
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA202848
Marketing category: ANDA
Marketing start: 2017-06-14
Substance: FLUOCINOLONE ACETONIDE
Active strength: .01 mg/100mL
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 1.

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
A202848-001	FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT		2013-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202848-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202848-001	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	2013-08-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202848-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202848-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202848-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202848-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202848-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202848-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202848-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202848-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202848-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202848-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202848-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202848-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202848-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202848-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202848-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202848-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202848-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202848-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202848-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202848-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202848-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202848-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202848-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202848-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202848-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202848-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202848-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202848-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202848-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202848-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202848-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202848-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202848-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202848-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202848-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202848-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202848-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202848-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202848-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202848-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINOLONE ACETONIDE	.01 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0CD5FD6S2M	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
7f8512d9-b4a4-43c6-bac6-3e75dc451db2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0adb2af5-1ecf-4df5-912b-16ae89228294	Product name	6	20240829
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
65f6255d-41cc-425f-ba54-b1bea4947886	Product name	5	20210930
5ba208e4-886f-44da-e218-ab4f4cad2c49	Product name	5	20190612
e5a2793f-318b-72fd-b734-c44ecc6f6748	Product name	2	20190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
7df2570a-c555-4d82-9189-9247c722b62c	Product name	1	20150402
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
a78a3633-fd06-b0af-63b3-c714de3b3bfa	Product name	1	20140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-485-26	Fluocinolone acetonide	1 in 1 CARTON	OIL	1		13
45802-485-26	Fluocinolone acetonide	118.28 mL in 1 BOTTLE	OIL	118.28		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-485-26	ML - Milliliter	45802-485	9a7b013a-6ace-4e29-b251-53f011ee3e8c	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-485	FLUOCINOLONE ACETONIDE OIL [PADAGIS ISRAEL PHARMACEUTICALS LTD]	12	Current NDC, Legacy NDC, 2 package rows	20250516_7f8512d9-b4a4-43c6-bac6-3e75dc451db2.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
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	A-S Medication Solutions	09284ede-6be9-4192-b178-567b3c6265bb	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202848 application number: ANDA202848
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	f674a0c0-df04-47e8-8d3f-a370182a596a	2025-10-29	Adverse reactions	Exact identifier application applno (ANDA): 202848 application number: ANDA202848
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	7f8512d9-b4a4-43c6-bac6-3e75dc451db2	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202848 application number: ANDA202848 ndc (package): 45802-485-26 ndc (product): 45802-485 ndc11 (package): 45802048526
Fluocinolone acetonide	FLUOCINOLONE ACETONIDE	Bryant Ranch Prepack	c9e2b99e-1f64-4c21-99a7-a18963be2237	2024-05-24	Adverse reactions	Exact identifier application applno (ANDA): 202848 application number: ANDA202848

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-485-26	45802048526	1 BOTTLE in 1 CARTON (45802-485-26) / 118.28 mL in 1 BOTTLE	1 bottle	2017-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinolone acetonide - A-S Medication Solutions	A-S Medication Solutions	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	1
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)	Bryant Ranch Prepack	2025-10-29	HUMAN PRESCRIPTION DRUG LABEL	101
Fluocinolone acetonide - Padagis Israel Pharmaceuticals Ltd	Padagis Israel Pharmaceuticals Ltd	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	13
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)	Bryant Ranch Prepack	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	109