Home NDC 72512-928 Qutenza
Product NDC 72512-928
11-digit product format 725120928
Labeler code 72512
Product ID 72512-928_d641ea90-cf4f-46b5-b309-1f06d4352086
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name capsaicin
Dosage form KIT
Labeler Averitas Pharma Inc
Application NDA022395
Marketing category NDA
Marketing start 2018-10-30
NDC exclude flag No
Listing certified through 2027-12-31
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 N022395-001 QUTENZA CAPSAICIN 8% PATCH / TOPICAL RLD, RS 2009-11-16
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022395-001 9226903 2028-12-15 Drug product 2020-01-08 N022395-001 8821920 2030-03-26 Drug product 2020-01-08
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 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 196 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 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 1e350fbaab3a…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Qutenza
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039679 Internal RxNorm lookup 1039681 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72512-920-00 Qutenza 1 in 1 POUCH PATCH 179 mg in 179mg 13 72512-920-00 Qutenza 1 in 1 CARTON PATCH 179 mg in 179mg 13 72512-928-01 Qutenza 1 in 1 CARTON KIT 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72512-928 QUTENZA (CAPSAICIN) KIT [AVERITAS PHARMA INC] 11 Current NDC, Legacy NDC, 3 package rows 20240810_3ffbbcb0-ad93-4f15-bb38-5da76a71c735.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 72512-920-00 72512092000 1 in 1 POUCH Historical 72512-928-01 72512092801 1 KIT in 1 CARTON (72512-928-01) * 1 POUCH in 1 CARTON (72512-920-00) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE 1 kit 2018-10-30 0000-00-00 No No Current