Home NDC 51672-1353 Fluocinonide
Product NDC 51672-1353
11-digit product format 516721353
Labeler code 51672
Product ID 51672-1353_390c3bf3-dd9d-f100-e063-6294a90a81f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA200734
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 A200734-001 FLUOCINONIDE FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200734-001 AB
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 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200734-001 FLUOCINONIDE 0.1% CREAM / TOPICAL AB 2014-07-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluocinonide ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Fluocinonide ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 carbomer homopolymer type c (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 4Q93RCW27E FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 diethylene glycol monoethyl ether INACTIVE INGREDIENT A1A1I8X02B FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polyoxyl 20 cetostearyl ether INACTIVE INGREDIENT YRC528SWUY FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 trolamine INACTIVE INGREDIENT 9O3K93S3TK FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1353 FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 6 package rows 20241222_16c7d142-e695-4e33-986f-78cb37f7b387.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 51672-1353-2 51672135302 1 TUBE in 1 CARTON (51672-1353-2) / 30 g in 1 TUBE 1 tube 2014-07-14 0000-00-00 No No Current 51672-1353-3 51672135303 1 TUBE in 1 CARTON (51672-1353-3) / 60 g in 1 TUBE 1 tube 2014-07-14 0000-00-00 No No Current 51672-1353-4 51672135304 1 TUBE in 1 CARTON (51672-1353-4) / 120 g in 1 TUBE 1 tube 2014-07-14 0000-00-00 No No Current