Home NDC 40032-026 fluocinonide
Product NDC 40032-026
11-digit product format 400320026
Labeler code 40032
Product ID 40032-026_09d4aa56-fa9a-4697-aeab-87ba2f0cca92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinonide
Dosage form SOLUTION
Route TOPICAL
Labeler Novel Laboratories, Inc.
Application ANDA206003
Marketing category ANDA
Marketing start 2017-07-21
Substance FLUOCINONIDE
Active strength .5 mg/mL
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 A206003-001 FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206003-001 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 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206003-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2017-07-21 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/mL
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 310364 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40032-026-06 fluocinonide 1 in 1 CARTON SOLUTION 1 1 40032-026-06 fluocinonide 60 mL in 1 BOTTLE SOLUTION 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-026 FLUOCINONIDE SOLUTION [NOVEL LABORATORIES, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20171130_f820f497-9ad9-482d-ac92-46a7afa58968.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 40032-026-06 40032002606 1 BOTTLE in 1 CARTON (40032-026-06) / 60 mL in 1 BOTTLE 1 bottle 2017-07-21 0000-00-00 No No Current