Home NDC 10337-450 Veregen
Product NDC 10337-450
11-digit product format 103370450
Labeler code 10337
Product ID 10337-450_e25d94c3-0838-41c0-92cb-ec04bf8165b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sinecatechins
Dosage form OINTMENT
Route TOPICAL
Labeler PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application NDA021902
Marketing category NDA
Marketing start 2007-12-14
Marketing end 2024-11-29
Substance SINECATECHINS
Active strength 150 mg/g
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 58 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N021902-001 VEREGEN SINECATECHINS 15% OINTMENT / TOPICAL RLD, RS 2006-10-31
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03
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 · 43 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 2026-09-14 22:38:34 2026-08 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 104 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021902-001 5795911 2020-10-31 U-172 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 10337-450-03 2020-08-25 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-08 2020-08-25 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-15 2020-08-25 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-99 2020-08-25 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-03 2020-07-22 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-08 2020-07-22 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-15 2020-07-22 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006 10337-450-99 2020-07-22 These highlights do not include all the information needed to use VEREGEN ® safely and effectively. See full prescribing information for VEREGEN ® . Veregen ® (sinecatechins) ointment, for topical use Initial U.S. Approval: 2006
DailyMed Socrata Ingredients# 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 Veregen SINECATECHINS ANI Pharmaceuticals, Inc. f0fc1e21-e3cf-4bce-860c-307f670b192e 2022-11-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 021902 application number: NDA021902
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10337-450-03 10337045003 1 TUBE in 1 CARTON (10337-450-03) > 30 g in 1 TUBE 1 tube 2007-12-14 0000-00-00 No No Current 10337-450-08 10337045008 1 TUBE in 1 CARTON (10337-450-08) > 2 g in 1 TUBE 1 tube 2007-12-14 0000-00-00 No No Current 10337-450-15 10337045015 1 TUBE in 1 CARTON (10337-450-15) > 15 g in 1 TUBE 1 tube 2007-12-14 0000-00-00 No No Current 10337-450-99 10337045099 1 TUBE in 1 CARTON (10337-450-99) > 4 g in 1 TUBE 1 tube 2007-12-14 0000-00-00 No No Current