Glycopyrrolate

Product NDC: 69067-050
Requested package NDC: 69067-050-30
11-digit product format: 690670050
Labeler code: 69067
Product ID: 69067-050_0bb70b28-bf45-4cc6-b64f-91b94c1eb0ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GLYCOPYRROLATE
Dosage form: TABLET
Route: ORAL
Labeler: Foxland Pharmaceuticals, Inc.
Application: ANDA091522
Marketing category: ANDA
Marketing start: 2018-10-10
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69067-050	69067-050-30	D	Discontinued by firm		2026-08-17

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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A091522-001	GLYCOPYRROLATE	1.5MG	TABLET / ORAL		2012-03-12	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69067-050-30	EA - Each	69067-050	d49e4c5b-82af-402c-bd13-254e58dc6611	1	2018-11-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69067-050-30	69067005030	30 TABLET in 1 BOTTLE (69067-050-30)	30 tablet	2018-10-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate Tablets, USP 1.5 mg	Foxland Pharmaceuticals, Inc.	2021-07-16	HUMAN PRESCRIPTION DRUG LABEL	3