Home NDC 68462-505-66 Fluocinonide
Product NDC 68462-505
Requested package NDC 68462-505-66
11-digit product format 684620505
Labeler code 68462
Product ID 68462-505_64f359f3-ab89-433a-9718-16a3c580c04f
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
Marketing end 0000-00-00
Substance FLUOCINONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2014-07-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091282-001 FLUOCINONIDE 0.1% CREAM / TOPICAL 2014-07-14 84e616aacf4f…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Legacy NDC, 3 package rows 20240104_50f1c216-78c6-4b93-b732-b3beeb78bd62.zip
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 68462-505-66 68462050566 120 g in 1 TUBE (68462-505-66) 120 g 2014-07-14 0000-00-00 No No Current