Home NDC 69489-411 Qbrexza
Product NDC 69489-411
11-digit product format 694890411
Labeler code 69489
Product ID 69489-411_52537ea0-9410-1691-e063-6394a90a9468
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
Substance GLYCOPYRRONIUM TOSYLATE
Active strength 2.4 g/100g
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Qbrexza
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRRONIUM TOSYLATE 2.4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1PVF6JLU7B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2054118 Internal RxNorm lookup 2054120 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 69489-411-01 Qbrexza 2.8 g in 1 POUCH CLOTH 2.8 5 69489-411-05 Qbrexza 5 in 1 CARTON CLOTH 5 5 69489-411-30 Qbrexza 30 in 1 CARTON CLOTH 30 5 69489-411-51 Qbrexza 2.8 g in 1 POUCH CLOTH 2.8 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69489-411 QBREXZA (GLYCOPYRRONIUM) CLOTH [JOURNEY MEDICAL CORPORATION] 4 Current NDC, Legacy NDC, 4 package rows 20231220_5b372650-e56e-47a5-93e2-c0c292017059.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 69489-411-01 69489041101 2.8 g in 1 POUCH 2.8 g Historical 69489-411-05 69489041105 5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51) 5 pouch 2021-12-03 0000-00-00 Yes No Current 69489-411-30 69489041130 30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01) 30 pouch 2021-12-03 0000-00-00 No No Current 69489-411-50 69489041150 5 POUCH in 1 CARTON (69489-411-50) > 2.8 g in 1 POUCH (69489-411-51) 5 pouch 2021-12-03 0000-00-00 Yes No Current 69489-411-51 69489041151 2.8 g in 1 POUCH 2.8 g Historical