Glycopyrrolate

Product NDC: 60763-476
11-digit product format: 607630476
Labeler code: 60763
Product ID: 60763-476_7ad108fa-ca17-1ced-e053-2a91aa0abc1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: TABLET
Route: ORAL
Labeler: Stason Pharmaceuticals, Inc.
Application: ANDA091182
Marketing category: ANDA
Marketing start: 2017-04-10
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: 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	60763-476		D	Discontinued by firm		2026-08-10
excluded package	package	60763-476	60763-476-02	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 · 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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60763-476-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60763-476-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60763-476-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60763-476-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60763-476-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60763-476-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60763-476-02	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60763-476-02	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60763-476-02	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60763-476-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60763-476-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60763-476-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60763-476-02	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60763-476-02	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60763-476-02	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	60763-476-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	60763-476-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	60763-476-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	60763-476-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091182-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2014-02-03
A091182-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2014-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091182-001	AA
A091182-002	AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091182-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2014-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091182-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2014-02-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091182-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091182-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091182-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091182-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091182-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091182-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091182-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091182-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091182-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091182-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091182-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091182-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091182-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091182-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091182-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091182-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091182-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091182-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091182-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091182-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091182-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091182-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091182-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091182-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091182-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091182-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091182-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091182-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091182-002	AA	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60763-476-02	2025-02-17	C162847	48780-1	ba0f9c33-0ea1-a910-e053-dadaa90a0b85	Glycopyrrolate 1 mg 2 mg
60763-476-02	2021-01-29	C162847	48780-1	ba0f9c33-0ea1-a910-e053-dadaa90a0b85	Glycopyrrolate 1 mg 2 mg

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ec15e70c-8473-469a-9f07-ea668783fa07	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182
Glycopyrrolate	GLYCOPYRROLATE	Florida Pharmaceutical Products, LLC	2cda1ed5-10bb-4651-acbf-be44ad709665	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	4c733750-45fe-4876-8e4f-c61c52470405	2023-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182
GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	e1ded8e0-c05b-4bf4-a129-57d1726af6ed	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091182 application number: ANDA091182