Glycopyrrolate

Product NDC: 50268-363
11-digit product format: 502680363
Labeler code: 50268
Product ID: 50268-363_2f8b2a36-ac60-7762-e063-6294a90ae573
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA202675
Marketing category: ANDA
Marketing start: 2025-03-04
Substance: GLYCOPYRROLATE
Active strength: 1 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
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	50268-363-15	`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	50268-363-15	`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	50268-363-15	`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	50268-363-15	`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	50268-363-15	`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	50268-363-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202675-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2013-04-15
A202675-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2018-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202675-001	AA
A202675-002	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	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202675-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2013-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202675-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2018-10-30	`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	A202675-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202675-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202675-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202675-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202675-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202675-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202675-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202675-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202675-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202675-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202675-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202675-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202675-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202675-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202675-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202675-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202675-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202675-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202675-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202675-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202675-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202675-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202675-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202675-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202675-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202675-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202675-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202675-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202675-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202675-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202675-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202675-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202675-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202675-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202675-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202675-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202675-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202675-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202675-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202675-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glycopyrrolate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCOPYRROLATE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V92SO9WP2I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197738	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bd497783-e2d1-130c-e053-2995a90a7fb9	Available on FDA.report

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
50268-363-11	Glycopyrrolate	1 in 1 BLISTER PACK	TABLET	1		4
50268-363-15	Glycopyrrolate	50 in 1 BOX	TABLET	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-363-11	EA - Each	50268-363	6b70c9cb-072c-4e89-9d5e-11481c26416b	1	2021-04-08
50268-363-15	EA - Each	50268-363	f6abeb85-7b99-4692-85bd-28bfbf27b08e	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-363	GLYCOPYRROLATE TABLET [AVPAK]	4	Current NDC, Legacy NDC, 2 package rows	20250308_bd497783-e2d1-130c-e053-2995a90a7fb9.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	REMEDYREPACK INC.	220cd5f5-3d71-4fdb-9943-7468799c179f	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	098c7654-a352-47ee-bf23-6a81f8601266	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	21c7d201-c0b8-4f16-be4a-681d0b22791e	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	NCS HealthCare of KY, LLC dba Vangard Labs	5ed930b7-a36e-4bf8-b1d1-dad238d3dd18	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	Aurolife Pharma LLC	677f8495-a870-45b6-bb65-75b449f040ce	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
GLYCOPYRROLATE	GLYCOPYRROLATE	American Health Packaging	6404fc8e-d109-4950-9dca-c8a85ad90cf3	2025-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675
Glycopyrrolate	GLYCOPYRROLATE	AvPAK	bd497783-e2d1-130c-e053-2995a90a7fb9	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202675 application number: ANDA202675 ndc (product): 50268-363

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	bd497783-e2d1-130c-e053-2995a90a7fb9	4
197738	glycopyrrolate 1 MG Oral Tablet	SCD	bd497783-e2d1-130c-e053-2995a90a7fb9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-363-11	50268036311	1 in 1 BLISTER PACK						Historical
50268-363-15	50268036315	50 BLISTER PACK in 1 BOX (50268-363-15) / 1 TABLET in 1 BLISTER PACK (50268-363-11)	50 blister pack	2025-03-04	0000-00-00	No	No	Current