Qbrexza

Product NDC: 70428-011
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70428-011		D	Discontinued by firm		2026-08-10
excluded package	package	70428-011	70428-011-12	D	Discontinued by firm		2026-08-10

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70428-011-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70428-011-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70428-011-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70428-011-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70428-011-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70428-011-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70428-011-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70428-011-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70428-011-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70428-011-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70428-011-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70428-011-12	`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	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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70428-011-11	EA - Each	70428-011	5ddccef4-837c-4d64-8e86-b7a9966f6b23	1	2019-04-11
70428-011-12	EA - Each	70428-011	b1bc7828-63b3-4737-9b80-7bdbb6859238	1	2018-09-05

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1PVF6JLU7B	GLYCOPYRRONIUM TOSYLATE	1624259-25-1	GLYCOPYRRONIUM TOSYLATE
A14FB57V1D	GLYCOPYRRONIUM	740028-90-4	glycopyrronium

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	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Qbrexza - Journey Medical Corporation \| Aphena Pharma Solutions, LLC	Journey Medical Corporation \| Aphena Pharma Solutions, LLC	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	6