Home NDC 70428-011-12 Qbrexza
Product NDC 70428-011
Requested package NDC 70428-011-12
11-digit product format 704280011
Labeler code 70428
Product ID 70428-011_c56af57e-1ebb-4507-9474-11acdd6ca2b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glycopyrronium
Dosage form CLOTH
Route TOPICAL
Labeler Journey Medical Corporation
Application NDA210361
Marketing category NDA
Marketing start 2018-06-28
Marketing end 2022-12-31
Substance GLYCOPYRRONIUM TOSYLATE
Active strength 2 g/100g
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N210361-001 QBREXZA GLYCOPYRRONIUM TOSYLATE EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28
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 N210361-001 10052267 2028-10-17 U-2398 Drug product 2018-09-20 N210361-001 8618160 2029-12-10 U-2398 Drug product 2018-09-20 N210361-001 9744105 2030-07-18 U-2398 Drug product 2018-09-20 N210361-001 10004717 2033-02-28 U-2398 Drug product 2018-09-20 N210361-001 10543192 2033-02-28 Drug product 2020-02-27 N210361-001 10548875 2033-02-28 U-2398 Drug substance, Drug product 2020-03-03 N210361-001 8859610 2033-02-28 U-2398 Drug product 2018-09-20 N210361-001 9259414 2033-02-28 U-2398 2018-09-20
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210361-001 QBREXZA EQ 2.4% BASE CLOTH / TOPICAL RLD, RS 2018-06-28 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 9 · 326 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210361-001 10052267 2028-10-17 U-2398 Drug product 2018-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 8618160 2029-12-10 U-2398 Drug product 2018-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 9744105 2030-07-18 U-2398 Drug product 2018-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 10004717 2033-02-28 U-2398 Drug product 2018-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 10543192 2033-02-28 Drug product 2020-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 10548875 2033-02-28 U-2398 Drug substance, Drug product 2020-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 8859610 2033-02-28 U-2398 Drug product 2018-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210361-001 9259414 2033-02-28 U-2398 2018-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 10052267 2028-10-17 U-2398 Drug product 2018-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 8618160 2029-12-10 U-2398 Drug product 2018-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 9744105 2030-07-18 U-2398 Drug product 2018-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 10004717 2033-02-28 U-2398 Drug product 2018-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 10543192 2033-02-28 Drug product 2020-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 10548875 2033-02-28 U-2398 Drug substance, Drug product 2020-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 8859610 2033-02-28 U-2398 Drug product 2018-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210361-001 9259414 2033-02-28 U-2398 2018-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210361-001 10052267 2028-10-17 U-2398 Drug product 2018-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 8618160 2029-12-10 U-2398 Drug product 2018-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 9744105 2030-07-18 U-2398 Drug product 2018-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 10004717 2033-02-28 U-2398 Drug product 2018-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 10543192 2033-02-28 Drug product 2020-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 10548875 2033-02-28 U-2398 Drug substance, Drug product 2020-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 8859610 2033-02-28 U-2398 Drug product 2018-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210361-001 9259414 2033-02-28 U-2398 2018-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 10052267 2028-10-17 U-2398 Drug product 2018-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 8618160 2029-12-10 U-2398 Drug product 2018-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 9744105 2030-07-18 U-2398 Drug product 2018-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 10004717 2033-02-28 U-2398 Drug product 2018-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 10543192 2033-02-28 Drug product 2020-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 10548875 2033-02-28 U-2398 Drug substance, Drug product 2020-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 8859610 2033-02-28 U-2398 Drug product 2018-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210361-001 9259414 2033-02-28 U-2398 2018-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 10052267 2028-10-17 U-2398 Drug product 2018-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 8618160 2029-12-10 U-2398 Drug product 2018-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 9744105 2030-07-18 U-2398 Drug product 2018-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 10004717 2033-02-28 U-2398 Drug product 2018-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 10543192 2033-02-28 Drug product 2020-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 10548875 2033-02-28 U-2398 Drug substance, Drug product 2020-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 8859610 2033-02-28 U-2398 Drug product 2018-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210361-001 9259414 2033-02-28 U-2398 2018-09-20 b8a1b40f171c…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 N210361-001 NP 2021-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210361-001 NP 2021-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210361-001 NP 2021-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210361-001 NP 2021-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210361-001 NP 2021-06-28 c0c555d07b60…
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 Qbrexza GLYCOPYRRONIUM Journey Medical Corporation 5b372650-e56e-47a5-93e2-c0c292017059 2026-05-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 210361 application number: NDA210361
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70428-011-12 70428001112 30 POUCH in 1 CARTON (70428-011-12) > 2.8 g in 1 POUCH (70428-011-11) 30 pouch 2018-06-28 2022-12-31 No No Current