Home NDC 47335-994 Winlevi
Product NDC 47335-994
11-digit product format 473350994
Labeler code 47335
Product ID 47335-994_2abfc28a-6f85-d793-e063-6394a90a9490
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clascoterone
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA213433
Marketing category NDA
Marketing start 2021-10-04
Substance CLASCOTERONE
Active strength 1 g/100g
Pharmacologic classes Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [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 N213433-001 WINLEVI CLASCOTERONE 1% CREAM / TOPICAL RLD, RS 2020-08-26
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213433-001 8143240 2027-01-12 U-2942 2020-09-04 N213433-001 11938141 2028-07-24 Drug product 2024-05-30 N213433-001 12337002 2028-07-24 U-3280 Drug product 2025-07-22 N213433-001 9486458 2028-07-24 U-2942 2020-09-04 N213433-001 10159682 2028-08-14 U-2942 2020-09-04 N213433-001 11207332 2028-11-20 U-3280 Drug product 2022-01-24 N213433-001 9433628 2029-02-28 Drug product 2020-09-04 N213433-001 8785427 2030-07-25 Drug product 2020-09-04
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.
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 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD 2020-08-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213433-001 WINLEVI 1% CREAM / TOPICAL RLD, RS 2020-08-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 313 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N213433-001 8143240 2027-01-12 U-2942 2020-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 11938141 2028-07-24 Drug product 2024-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 12337002 2028-07-24 U-3280 Drug product 2025-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 9486458 2028-07-24 U-2942 2020-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 10159682 2028-08-14 U-2942 2020-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 11207332 2028-11-20 U-3280 Drug product 2022-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 9433628 2029-02-28 Drug product 2020-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213433-001 8785427 2030-07-25 Drug product 2020-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213433-001 8143240 2027-01-12 U-2942 2020-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 11938141 2028-07-24 Drug product 2024-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 12337002 2028-07-24 U-3280 Drug product 2025-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 9486458 2028-07-24 U-2942 2020-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 10159682 2028-08-14 U-2942 2020-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 11207332 2028-11-20 U-3280 Drug product 2022-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 9433628 2029-02-28 Drug product 2020-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213433-001 8785427 2030-07-25 Drug product 2020-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 9211295 2025-05-31 Drug product 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 8865690 2025-12-27 U-2942 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 8143240 2026-01-12 U-2942 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 11938141 2028-07-24 Drug product 2024-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 12337002 2028-07-24 U-3280 Drug product 2025-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 9486458 2028-07-24 U-2942 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 10159682 2028-08-14 U-2942 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 11207332 2028-11-20 U-3280 Drug product 2022-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 9433628 2029-02-28 Drug product 2020-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213433-001 8785427 2030-07-25 Drug product 2020-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213433-001 9211295 2025-05-31 Drug product 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 8865690 2025-12-27 U-2942 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 8143240 2026-01-12 U-2942 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 11938141 2028-07-24 Drug product 2024-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 12337002 2028-07-24 U-3280 Drug product 2025-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 9486458 2028-07-24 U-2942 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 10159682 2028-08-14 U-2942 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 11207332 2028-11-20 U-3280 Drug product 2022-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 9433628 2029-02-28 Drug product 2020-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213433-001 8785427 2030-07-25 Drug product 2020-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213433-001 9211295 2025-05-31 Drug product 2020-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213433-001 8865690 2025-07-24 U-2942 2020-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213433-001 8143240 2026-01-12 U-2942 2020-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213433-001 11938141 2028-07-24 Drug product 2024-05-30 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Winlevi
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLASCOTERONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XN7MM8XG2M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2474344 Internal RxNorm lookup 2474349 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-994 WINLEVI (CLASCOTERONE) CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 5 package rows 20250104_1673a84b-7f5c-47ab-a99c-1e3db21a6a09.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Winlevi CLASCOTERONE Sun Pharmaceutical Industries, Inc. 1673a84b-7f5c-47ab-a99c-1e3db21a6a09 2025-01-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 213433 application number: NDA213433 ndc (product): 47335-994
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 47335-994-36 47335099436 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE 1 tube 2021-10-04 0000-00-00 No No Current 47335-994-40 47335099440 2 g in 1 TUBE 2 g Historical 47335-994-94 47335099494 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE 12 carton 2021-10-04 0000-00-00 Yes No Current