Home NDC 0093-0263-92 Fluocinonide
Product NDC 0093-0263
Requested package NDC 0093-0263-92
11-digit product format 000930263
Labeler code 0093
Product ID 0093-0263_c70aebe7-b63b-468a-ada5-dc1e60391277
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form CREAM
Route TOPICAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA072490
Marketing category ANDA
Marketing start 1990-09-30
Substance FLUOCINONIDE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 12 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A072490-001 FLUOCINONIDE EMULSIFIED BASE FLUOCINONIDE 0.05% CREAM / TOPICAL AB2 1989-02-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072490-001 AB2
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 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072490-001 FLUOCINONIDE EMULSIFIED BASE 0.05% CREAM / TOPICAL AB2 1989-02-07 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 Fluocinonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINONIDE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2W4A77YPAN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103456 Internal RxNorm lookup 103457 Internal RxNorm lookup 1801283 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-0263 FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20241225_986c1ba3-2103-4773-a35c-2c0121a01783.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 0093-0263-92 00093026392 1 TUBE in 1 CARTON (0093-0263-92) / 60 g in 1 TUBE 1 tube 1990-09-30 0000-00-00 No No Current