Glycopyrrolate

Product NDC: 70518-3031
Requested package NDC: 70518-3031-0
11-digit product format: 705183031
Labeler code: 70518
Product ID: 70518-3031_4dec8664-b51f-da36-e063-6294a90a4edb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA207201
Marketing category: ANDA
Marketing start: 2021-02-25
Substance: GLYCOPYRROLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 11 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…`

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
A207201-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2017-01-03
A207201-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2017-01-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207201-001	AA
A207201-002	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	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207201-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2017-01-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207201-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2017-01-03	`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	A207201-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207201-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207201-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207201-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207201-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207201-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207201-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207201-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207201-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207201-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207201-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207201-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207201-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207201-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207201-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207201-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207201-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207201-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207201-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207201-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207201-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207201-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207201-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207201-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207201-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207201-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207201-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207201-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207201-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glycopyrrolate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCOPYRROLATE	2 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
197739	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
fafea739-87d0-4421-833f-eb066791504c	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3031-0	2023-03-15	C162847	48780-1	f386c64a-4907-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets for oral use Initial U.S. Approval: 1961
70518-3031-0	2023-01-30	C162847	48780-1	f386c64a-4907-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3031-0	Glycopyrrolate	100 in 1 BOX	TABLET	100		5
70518-3031-1	Glycopyrrolate	1 in 1 POUCH	TABLET	1		5

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	a338ef22-c243-4075-b02d-bcd5b590104a	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	fafea739-87d0-4421-833f-eb066791504c	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201 ndc (package): 70518-3031-0 ndc (product): 70518-3031 ndc11 (package): 70518303100
Glycopyrrolate	GLYCOPYRROLATE	Major Pharmaceuticals	6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201
Glycopyrrolate	GLYCOPYRROLATE	Chartwell RX, LLC	5773cf63-4006-4d8f-b53b-c84bcfe19e4a	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	bfccdb26-5047-4b54-9732-ffac2d78e4d1	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201
Glycopyrrolate	GLYCOPYRROLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	26cdd84d-ffa0-4e52-b359-4acef4bd8093	2022-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207201 application number: ANDA207201

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
197739	glycopyrrolate 2 MG Oral Tablet	PSN	fafea739-87d0-4421-833f-eb066791504c	5
197739	glycopyrrolate 2 MG Oral Tablet	SCD	fafea739-87d0-4421-833f-eb066791504c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3031-0	70518303100	100 POUCH in 1 BOX (70518-3031-0) / 1 TABLET in 1 POUCH (70518-3031-1)	100 pouch	2021-02-25	0000-00-00	No	No	Current