Home NDC 76420-530 Fluocinonide
Product NDC 76420-530
11-digit product format 764200530
Labeler code 76420
Product ID 76420-530_efb3276f-d261-59b5-e053-2a95a90ab9fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form CREAM
Route TOPICAL
Labeler Asclemed USA, Inc.
Application ANDA211111
Marketing category ANDA
Marketing start 2018-07-31
Substance FLUOCINONIDE
Active strength 1 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 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 A211111-001 FLUOCINONIDE FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04
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 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2018-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211111-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2018-06-04 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fluocinonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINONIDE 1 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 485647 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 76420-530-06 Fluocinonide 60 g in 1 TUBE CREAM 60 1 76420-530-06 Fluocinonide 1 in 1 CARTON CREAM 1 1 76420-530-12 Fluocinonide 120 g in 1 TUBE CREAM 120 1 76420-530-12 Fluocinonide 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-530 FLUOCINONIDE CREAM [ASCLEMED USA, INC.] 1 Current NDC, Legacy NDC, 4 package rows 20221217_b387f926-1109-41b2-9fe0-f77db6b10280.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 76420-530-06 76420053006 1 TUBE in 1 CARTON (76420-530-06) / 60 g in 1 TUBE 1 tube 2022-12-13 0000-00-00 No No Current 76420-530-12 76420053012 1 TUBE in 1 CARTON (76420-530-12) / 120 g in 1 TUBE 1 tube 2022-12-13 0000-00-00 No No Current