GLYCOPYRROLATE

Product NDC: 60429-665
11-digit product format: 604290665
Labeler code: 60429
Product ID: 60429-665_f784b3c5-39be-1cac-e053-6294a90a0315
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GLYCOPYRROLATE
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA091182
Marketing category: ANDA
Marketing start: 2014-02-03
Substance: GLYCOPYRROLATE
Active strength: 1 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	60429-665		D	Discontinued by firm		2026-08-10
excluded package	package	60429-665	60429-665-01	D	Discontinued by firm		2026-08-10

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…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60429-665-01	GLYCOPYRROLATE	100 in 1 BOTTLE	TABLET	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-665-01	EA - Each	60429-665	f9ee452f-5a18-4013-bb09-9de2b7d1cb7b	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60429-665	GLYCOPYRROLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20230325_ec15e70c-8473-469a-9f07-ea668783fa07.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 · 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 ndc (product): 60429-665
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

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
197738	glycopyrrolate 1 MG Oral Tablet	PSN	ec15e70c-8473-469a-9f07-ea668783fa07	9
197739	glycopyrrolate 2 MG Oral Tablet	PSN	ec15e70c-8473-469a-9f07-ea668783fa07	9
197738	glycopyrrolate 1 MG Oral Tablet	SCD	ec15e70c-8473-469a-9f07-ea668783fa07	9
197739	glycopyrrolate 2 MG Oral Tablet	SCD	ec15e70c-8473-469a-9f07-ea668783fa07	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-665-01	60429066501	100 TABLET in 1 BOTTLE (60429-665-01)	100 tablet	2016-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYCOPYRROLATE TABLETS USP	Golden State Medical Supply, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	9