Glycopyrrolate

Product NDC: 0722-7097
11-digit product format: 007227097
Labeler code: 0722
Product ID: 0722-7097_9e901d90-08ba-4143-8e0c-1bd15b72e0de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: TABLET
Route: ORAL
Labeler: Nexgen Pharma, Inc.
Application: ANDA091522
Marketing category: ANDA
Marketing start: 2012-03-12
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0722-7097		I	Inactivated by FDA		2026-10-02
excluded package	package	0722-7097	0722-7097-01	I	Inactivated by FDA		2026-10-02

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 · 38 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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`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	0722-7097-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0722-7097-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0722-7097-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0722-7097-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0722-7097-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0722-7097-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0722-7097-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0722-7097-01	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091522-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		RS	2012-03-12

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL	RS	2012-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
138c3de2-4b03-4255-92b5-f022482d81bc	Product name	4	20260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810e	Product name	5	20250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b	Product name	1	20231002
76dcac30-469f-4f92-9c55-70950d209446	Product name	1	20230809
132196a6-5117-4b6e-a9dd-27f2793580c6	Product name	1	20230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1b	Product name	1	20220720
d84dd569-7bf0-1410-25eb-017ef37dd406	Product name	9	20210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
58b12de9-b891-41c7-9be6-ff47de5ec28b	Product name	1	20180828
9aff7b10-8e47-4b10-9a92-803440a37ce2	Product name	1	20180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75a	Product name	1	20151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6	Product name	1	20151109
29ae08d1-069f-9822-4820-152d5dc67797	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0722-7097-01	2021-01-29	C162847	48780-1	ba0f9c33-3c90-a910-e053-dadaa90a0b85	GLYCOPYRROLATE TABLETS, USP, 1.5 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0722-7097-01	Glycopyrrolate	100 in 1 BOTTLE, PLASTIC	TABLET	100		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCOPYRROLATE	ACTIVE INGREDIENT	V92SO9WP2I	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1
GLYCOPYRROLATE	ACTIVE MOIETY	V92SO9WP2I	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1
CALCIUM PYROPHOSPHATE	INACTIVE INGREDIENT	X69NU20D19	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0722-7097	GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.]	3	Legacy NDC, 1 package rows	20190910_06bb6f89-4694-4aaa-8bff-f7f3c81d3add.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycate	GLYCOPYRROLATE	Intra-Sana Laboratories	830ba1be-bef3-417c-a915-964cc6005b92	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091522 application number: ANDA091522
GLYCOPYRROLATE	GLYCOPYRROLATE	FH2 Pharma LLC	18ca98ed-522d-470f-bb22-908bbd7d489a	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091522 application number: ANDA091522
Glycopyrrolate	GLYCOPYRROLATE	LGM PHARMA SOLUTIONS, LLC	392a969d-1e14-4ad8-835c-a47be4983067	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091522 application number: ANDA091522

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V92SO9WP2I	GLYCOPYRROLATE	51186-83-5	GLYCOPYRROLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1247658	glycopyrrolate 1.5 MG Oral Tablet	PSN	06bb6f89-4694-4aaa-8bff-f7f3c81d3add	3
1247658	glycopyrrolate 1.5 MG Oral Tablet	SCD	06bb6f89-4694-4aaa-8bff-f7f3c81d3add	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0722-7097-01	00722709701	100 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYCOPYRROLATE TABLETS, USP, 1.5 MG	Nexgen Pharma, Inc. \| Nexgen Pharma, Inc	2019-09-06	HUMAN PRESCRIPTION DRUG LABEL	3