Home NDC 0713-0663-31 Fluocinonide
Product NDC 0713-0663
Requested package NDC 0713-0663-31
11-digit product format 007130663
Labeler code 0713
Product ID 0713-0663_f0d2ff2b-732c-ae99-e053-2995a90a1ee7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA073085
Marketing category ANDA
Marketing start 2022-11-16
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 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 A073085-001 FLUOCINONIDE FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073085-001 AB1
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 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073085-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 1992-02-14 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103456 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0663 FLUOCINONIDE CREAM [COSETTE PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 6 package rows 20221228_e3348b90-8c16-4788-ab61-e354aea5d0a8.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 0713-0663-31 00713066331 1 TUBE in 1 CARTON (0713-0663-31) / 30 g in 1 TUBE 1 tube 2022-11-16 0000-00-00 No No Current