Home NDC 62559-385 Veregen
Product NDC 62559-385
11-digit product format 625590385
Labeler code 62559
Product ID 62559-385_64ad4fa5-8381-41db-8d9b-62fa44843180
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sinecatechins
Dosage form OINTMENT
Route TOPICAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA021902
Marketing category NDA
Marketing start 2022-11-10
Substance SINECATECHINS
Active strength 150 mg/g
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Veregen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SINECATECHINS 150 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T432289GYZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 753350 Internal RxNorm lookup 795918 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-385 VEREGEN (SINECATECHINS) OINTMENT [ANI PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 5 package rows 20221115_f0fc1e21-e3cf-4bce-860c-307f670b192e.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 62559-385-02 62559038502 1 in 1 CARTON Historical 62559-385-26 62559038526 6 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBE 6 carton 2022-11-10 0000-00-00 Yes No Current 62559-385-30 62559038530 1 TUBE in 1 CARTON (62559-385-30) / 30 g in 1 TUBE 1 tube 2022-11-10 0000-00-00 No No Current