Home NDC 0168-0064 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 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 A088168-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088168-001 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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088168-001 FLUOCINOLONE ACETONIDE 0.025% OINTMENT / TOPICAL AT 1982-12-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 .25 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191256 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0168-0064-15 2025-08-11 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-60 2025-08-11 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-15 2025-07-29 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-60 2025-07-29 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-15 2020-09-14 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-60 2020-09-14 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-15 2020-07-22 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025% 0168-0064-60 2020-07-22 FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0064-15 Fluocinolone Acetonide 15 g in 1 TUBE OINTMENT 15 11 0168-0064-60 Fluocinolone Acetonide 60 g in 1 TUBE OINTMENT 60 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0064 FLUOCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 2 package rows 20200915_49552e29-7813-4726-b15d-63bd975b6588.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0168-0064-15 00168006415 15 g in 1 TUBE (0168-0064-15) 15 g 1982-12-16 0000-00-00 No No Current 0168-0064-60 00168006460 60 g in 1 TUBE (0168-0064-60) 60 g 1982-12-16 0000-00-00 No No Current