Home NDC 33342-320-85 Fluocinonide
Product NDC 33342-320
Requested package NDC 33342-320-85
11-digit product format 333420320
Labeler code 33342
Product ID 33342-320_3e29d28d-6fd2-4abd-9f42-01ac5f421beb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form SOLUTION
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA209283
Marketing category ANDA
Marketing start 2018-04-24
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 A209283-001 FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209283-001 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 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209283-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT 2018-04-23 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 33342-320-84 Fluocinonide 20 mL in 1 BOTTLE SOLUTION 20 2 33342-320-84 Fluocinonide 1 in 1 CARTON SOLUTION 1 2 33342-320-85 Fluocinonide 60 mL in 1 BOTTLE SOLUTION 60 2 33342-320-85 Fluocinonide 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-320 FLUOCINONIDE SOLUTION [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 4 package rows 20240415_a439ac59-42f3-412b-b987-14fc152a974f.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 · 3 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 33342-320-85 33342032085 1 BOTTLE in 1 CARTON (33342-320-85) / 60 mL in 1 BOTTLE 1 bottle 2018-04-24 0000-00-00 No No Current