Home NDC 68462-505 Fluocinonide
Product NDC 68462-505
11-digit product format 684620505
Labeler code 68462
Product ID 68462-505_9c6c8ea8-4836-4bb8-882b-2375184485d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA091282
Marketing category ANDA
Marketing start 2014-07-14
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 A091282-001 FLUOCINONIDE FLUOCINONIDE 0.1% CREAM / TOPICAL 2014-07-14
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 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2014-07-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2014-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2014-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 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 68462-505-35 Fluocinonide 30 g in 1 TUBE CREAM 30 6 68462-505-65 Fluocinonide 60 g in 1 TUBE CREAM 60 6 68462-505-66 Fluocinonide 120 g in 1 TUBE CREAM 120 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUOCINONIDE ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 FLUOCINONIDE ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 CETEARETH-100 INACTIVE INGREDIENT DK070R75PW FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 DIETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT A1A1I8X02B FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 DIISOPROPANOLAMINE INACTIVE INGREDIENT 0W44HYL8T5 FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-505 FLUOCINONIDE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 6 Current NDC, Legacy NDC, 3 package rows 20240104_50f1c216-78c6-4b93-b732-b3beeb78bd62.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 68462-505-35 68462050535 30 g in 1 TUBE (68462-505-35) 30 g 2014-07-14 0000-00-00 No No Current 68462-505-65 68462050565 60 g in 1 TUBE (68462-505-65) 60 g 2014-07-14 0000-00-00 No No Current 68462-505-66 68462050566 120 g in 1 TUBE (68462-505-66) 120 g 2014-07-14 0000-00-00 No No Current