Home NDC 0093-0264-30 Fluocinonide
Product NDC 0093-0264
Requested package NDC 0093-0264-30
11-digit product format 000930264
Labeler code 0093
Product ID 0093-0264_c70aebe7-b63b-468a-ada5-dc1e60391277
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form OINTMENT
Route TOPICAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA073481
Marketing category ANDA
Marketing start 1992-05-01
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 A073481-001 FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073481-001 AB
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 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073481-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB 1991-12-27 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# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOCINONIDE ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 FLUOCINONIDE ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] 1 FLUOCINONIDE ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 FLUOCINONIDE ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] 1 FLUOCINONIDE ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 FLUOCINONIDE ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 1,2,6-HEXANETRIOL INACTIVE INGREDIENT W45XXM0XWE FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 1,2,6-HEXANETRIOL INACTIVE INGREDIENT W45XXM0XWE FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 CARBOMER HOMOPOLYMER TYPE B INACTIVE INGREDIENT HHT01ZNK31 FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOCINONIDE CREAM FLUOCINONIDE OINTMENT [TEVA PHARMACEUTICALS USA INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-0264 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 · 2 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 0093-0264-30 00093026430 1 TUBE in 1 CARTON (0093-0264-30) / 30 g in 1 TUBE 1 tube 1992-05-01 0000-00-00 No No Current