fluocinolone acetonide

Product NDC: 62559-288
Requested package NDC: 62559-288-60
11-digit product format: 625590288
Labeler code: 62559
Product ID: 62559-288_9a3159b1-5a5c-4784-8f61-a132de5c4608
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluocinolone acetonide
Dosage form: CREAM
Route: TOPICAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA012787
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-05-08
Substance: FLUOCINOLONE ACETONIDE
Active strength: .1 mg/g
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N012787-002	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
N012787-004	SYNALAR	FLUOCINOLONE ACETONIDE	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
N012787-005	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N012787-002	AT
N012787-004	AT
N012787-005	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N012787-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-004	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-005	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-004	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-005	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012787-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-004	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-005	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-004	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-005	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-004	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-005	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-004	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-005	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-004	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-005	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-004	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-005	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-004	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-005	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012787-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-004	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-005	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-004	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-005	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-004	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012787-005	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-004	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012787-005	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012787-002	AT	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINOLONE ACETONIDE	.1 mg/g

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191302	Internal RxNorm lookup
1191315	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
50e7006d-a51b-49aa-8e1c-330340e7bf82	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
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	SPL version
62559-288-15	fluocinolone acetonide	15 g in 1 TUBE	CREAM	15	3
62559-288-15	fluocinolone acetonide	1 in 1 CARTON	CREAM	1	3
62559-288-60	fluocinolone acetonide	60 g in 1 TUBE	CREAM	60	3
62559-288-60	fluocinolone acetonide	1 in 1 CARTON	CREAM	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-288-15	GM - Gram	62559-288	b5f115f8-ce8d-4b9d-8de8-11f693126fde	1	2024-06-10
62559-288-60	GM - Gram	62559-288	19e27571-8293-415f-9b8d-24da84ba8f59	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-288	FLUOCINOLONE ACETONIDE CREAM [ANI PHARMACEUTICALS, INC.]	2	Current NDC, 4 package rows	20240920_50e7006d-a51b-49aa-8e1c-330340e7bf82.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	50e7006d-a51b-49aa-8e1c-330340e7bf82	2026-02-23	Adverse reactions	Exact identifier application applno (NDA): 012787 application number: NDA012787 ndc (package): 62559-288-60 ndc (product): 62559-288 ndc11 (package): 62559028860
Synalar	FLUOCINOLONE ACETONIDE	Medimetriks Pharmaceuticals, Inc.	5af2e4c1-082b-48a0-aae7-72d4a68cbb2d	2024-07-18	Adverse reactions	Exact identifier application applno (NDA): 012787 application number: NDA012787

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191302	fluocinolone acetonide 0.01 % Topical Cream	PSN	50e7006d-a51b-49aa-8e1c-330340e7bf82	3
1191315	fluocinolone acetonide 0.025 % Topical Cream	PSN	50e7006d-a51b-49aa-8e1c-330340e7bf82	3
1191302	fluocinolone acetonide 0.1 MG/ML Topical Cream	SCD	50e7006d-a51b-49aa-8e1c-330340e7bf82	3
1191315	fluocinolone acetonide 0.25 MG/ML Topical Cream	SCD	50e7006d-a51b-49aa-8e1c-330340e7bf82	3
1191302	fluocinolone acetonide 0.01 % Topical Cream	SY	50e7006d-a51b-49aa-8e1c-330340e7bf82	3
1191315	fluocinolone acetonide 0.025 % Topical Cream	SY	50e7006d-a51b-49aa-8e1c-330340e7bf82	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62559-288-60	62559028860	1 TUBE in 1 CARTON (62559-288-60) / 60 g in 1 TUBE	1 tube	2024-05-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluocinolone Acetonide Cream USP, 0.01% and 0.025% Rx Only	ANI Pharmaceuticals, Inc.	2026-02-23	HUMAN PRESCRIPTION DRUG LABEL	3