FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
0168-0064
11-digit product format
001680064
Labeler code
0168
Product ID
0168-0064_2034c4ef-c138-44bd-9101-a7b7660f9d18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA088168
Marketing category
ANDA
Marketing start
1982-12-16
Substance
FLUOCINOLONE ACETONIDE
Active strength
.25 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088168-001FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE0.025%OINTMENT / TOPICALAT1982-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088168-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A088168-001FLUOCINOLONE ACETONIDE0.025%OINTMENT / TOPICALAT1982-12-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A088168-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC49552e29-7813-4726-b15d-63bd975b65882026-01-28Adverse reactionsExact identifier
application applno (ANDA): 088168
application number: ANDA088168
ndc (product): 0168-0064

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinolone Acetonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0CD5FD6S2MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1191256Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49552e29-7813-4726-b15d-63bd975b6588Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0064-152025-08-11C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-602025-08-11C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-152025-07-29C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-602025-07-29C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-152020-09-14C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-602020-09-14C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-152020-07-22C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
0168-0064-602020-07-22C16284748780-1ab0e2407-31a5-f274-e053-dbdaa90a6471FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0064-15Fluocinolone Acetonide15 g in 1 TUBEOINTMENT1511
0168-0064-60Fluocinolone Acetonide60 g in 1 TUBEOINTMENT6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0064-15GM - Gram0168-0064b370ccba-a290-4ecd-b596-5425721f9e2512012-07-24
0168-0064-60GM - Gram0168-00644d750ea6-8a6c-48fb-aaa3-c386fcbbdb0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
petrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0064FLUOCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20200915_49552e29-7813-4726-b15d-63bd975b6588.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191256fluocinolone acetonide 0.025 % Topical OintmentPSN49552e29-7813-4726-b15d-63bd975b658811
1191256fluocinolone acetonide 0.00025 MG/MG Topical OintmentSCD49552e29-7813-4726-b15d-63bd975b658811
1191256fluocinolone acetonide 0.025 % Topical OintmentSY49552e29-7813-4726-b15d-63bd975b658811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0064-150016800641515 g in 1 TUBE (0168-0064-15) 15 g1982-12-160000-00-00NoNoCurrent
0168-0064-600016800646060 g in 1 TUBE (0168-0064-60) 60 g1982-12-160000-00-00NoNoCurrent