Home NDC 0168-0059-60 Fluocinolone Acetonide
Product NDC 0168-0059
Requested package NDC 0168-0059-60
11-digit product format 001680059
Labeler code 0168
Product ID 0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form SOLUTION
Route TOPICAL
Labeler Fougera Pharmaceuticals, LLC
Application ANDA088167
Marketing category ANDA
Marketing start 1982-12-16
Substance FLUOCINOLONE ACETONIDE
Active strength .1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
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 A088167-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION / 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 A088167-001 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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088167-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 1982-12-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 .1 mg/mL
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 1191310 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0059-60 Fluocinolone Acetonide 60 mL in 1 BOTTLE SOLUTION 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluocinolone acetonide ACTIVE INGREDIENT 0CD5FD6S2M FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 fluocinolone acetonide ACTIVE MOIETY 0CD5FD6S2M FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 FLUOCINOLONE ACETONIDE ACTIVE INGREDIENT 0CD5FD6S2M FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 FLUOCINOLONE ACETONIDE ACTIVE MOIETY 0CD5FD6S2M FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0059 FLUOCINOLONE ACETONIDE SOLUTION [FOUGERA PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20231206_5649e15a-6a7c-4752-ac28-01e453afb37e.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 0168-0059-60 00168005960 60 mL in 1 BOTTLE (0168-0059-60) 60 ml 1982-12-16 0000-00-00 No No Current