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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210361-001QBREXZAGLYCOPYRRONIUM TOSYLATEEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210361-001100522672028-10-17U-2398Drug product2018-09-20
N210361-00186181602029-12-10U-2398Drug product2018-09-20
N210361-00197441052030-07-18U-2398Drug product2018-09-20
N210361-001100047172033-02-28U-2398Drug product2018-09-20
N210361-001105431922033-02-28Drug product2020-02-27
N210361-001105488752033-02-28U-2398Drug substance, Drug product2020-03-03
N210361-00188596102033-02-28U-2398Drug product2018-09-20
N210361-00192594142033-02-28U-23982018-09-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210361-001QBREXZAEQ 2.4% BASECLOTH / TOPICALRLD, RS2018-06-28cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 9 · 326 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210361-001100522672028-10-17U-2398Drug product2018-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-00186181602029-12-10U-2398Drug product2018-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-00197441052030-07-18U-2398Drug product2018-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-001100047172033-02-28U-2398Drug product2018-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-001105431922033-02-28Drug product2020-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-001105488752033-02-28U-2398Drug substance, Drug product2020-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-00188596102033-02-28U-2398Drug product2018-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210361-00192594142033-02-28U-23982018-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-001100522672028-10-17U-2398Drug product2018-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-00186181602029-12-10U-2398Drug product2018-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-00197441052030-07-18U-2398Drug product2018-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-001100047172033-02-28U-2398Drug product2018-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-001105431922033-02-28Drug product2020-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-001105488752033-02-28U-2398Drug substance, Drug product2020-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-00188596102033-02-28U-2398Drug product2018-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210361-00192594142033-02-28U-23982018-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N210361-001100522672028-10-17U-2398Drug product2018-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-00186181602029-12-10U-2398Drug product2018-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-00197441052030-07-18U-2398Drug product2018-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-001100047172033-02-28U-2398Drug product2018-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-001105431922033-02-28Drug product2020-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-001105488752033-02-28U-2398Drug substance, Drug product2020-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-00188596102033-02-28U-2398Drug product2018-09-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210361-00192594142033-02-28U-23982018-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-001100522672028-10-17U-2398Drug product2018-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-00186181602029-12-10U-2398Drug product2018-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-00197441052030-07-18U-2398Drug product2018-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-001100047172033-02-28U-2398Drug product2018-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-001105431922033-02-28Drug product2020-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-001105488752033-02-28U-2398Drug substance, Drug product2020-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-00188596102033-02-28U-2398Drug product2018-09-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210361-00192594142033-02-28U-23982018-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-001100522672028-10-17U-2398Drug product2018-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-00186181602029-12-10U-2398Drug product2018-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-00197441052030-07-18U-2398Drug product2018-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-001100047172033-02-28U-2398Drug product2018-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-001105431922033-02-28Drug product2020-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-001105488752033-02-28U-2398Drug substance, Drug product2020-03-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-00188596102033-02-28U-2398Drug product2018-09-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210361-00192594142033-02-28U-23982018-09-20b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-12-28 21:50 UTC2021-12N210361-001NP2021-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210361-001NP2021-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N210361-001NP2021-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210361-001NP2021-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210361-001NP2021-06-28c0c555d07b60…

Additional Listing Data#

Finished product
Yes
Brand name base
Qbrexza
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRRONIUM TOSYLATE2.4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1PVF6JLU7BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2054118Internal RxNorm lookup
2054120Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b372650-e56e-47a5-93e2-c0c292017059Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
138c3de2-4b03-4255-92b5-f022482d81bcProduct name420260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810eProduct name520250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69489-411-01Qbrexza2.8 g in 1 POUCHCLOTH2.85
69489-411-05Qbrexza5 in 1 CARTONCLOTH55
69489-411-30Qbrexza30 in 1 CARTONCLOTH305
69489-411-51Qbrexza2.8 g in 1 POUCHCLOTH2.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69489-411-01EA - Each69489-4118713448d-76d9-4960-878a-4f3fb6e4459212021-12-08
69489-411-30EA - Each69489-411fcaa28fe-bf49-4df9-b566-b824a6c6c10912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69489-411QBREXZA (GLYCOPYRRONIUM) CLOTH [JOURNEY MEDICAL CORPORATION]4Current NDC, Legacy NDC, 4 package rows20231220_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QbrexzaGLYCOPYRRONIUMJourney Medical Corporation5b372650-e56e-47a5-93e2-c0c2920170592026-05-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 210361
application number: NDA210361
ndc (product): 69489-411

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054118glycopyrronium 2.4 % Medicated ClothPSN5b372650-e56e-47a5-93e2-c0c2920170595
2054120Qbrexza 2.4 % Medicated ClothPSN5b372650-e56e-47a5-93e2-c0c2920170595
2054120glycopyrronium 24 MG/ML Medicated Pad [Qbrexza]SBD5b372650-e56e-47a5-93e2-c0c2920170595
2054118glycopyrronium 24 MG/ML Medicated PadSCD5b372650-e56e-47a5-93e2-c0c2920170595
2054118glycopyrronium 2.4 % Medicated ClothSY5b372650-e56e-47a5-93e2-c0c2920170595
2054120Qbrexza 2.4 % Medicated ClothSY5b372650-e56e-47a5-93e2-c0c2920170595
2054120Qbrexza 24 MG/ML Medicated PadSY5b372650-e56e-47a5-93e2-c0c2920170595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69489-411-01694890411012.8 g in 1 POUCH2.8 gHistorical
69489-411-05694890411055 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51) 5 pouch2021-12-030000-00-00YesNoCurrent
69489-411-306948904113030 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01) 30 pouch2021-12-030000-00-00NoNoCurrent
69489-411-50694890411505 POUCH in 1 CARTON (69489-411-50) > 2.8 g in 1 POUCH (69489-411-51) 5 pouch2021-12-030000-00-00YesNoCurrent
69489-411-51694890411512.8 g in 1 POUCH2.8 gHistorical