Glycopyrrolate

Product NDC: 71335-2075
11-digit product format: 713352075
Labeler code: 71335
Product ID: 71335-2075_91ae221e-608d-42a1-81a1-352781e527ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207201
Marketing category: ANDA
Marketing start: 2017-02-27
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

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: 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
bfccdb26-5047-4b54-9732-ffac2d78e4d1	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	SPL version
71335-2075-1	Glycopyrrolate	30 in 1 BOTTLE	TABLET	30	102
71335-2075-2	Glycopyrrolate	270 in 1 BOTTLE	TABLET	270	102
71335-2075-3	Glycopyrrolate	28 in 1 BOTTLE	TABLET	28	102
71335-2075-4	Glycopyrrolate	90 in 1 BOTTLE	TABLET	90	102
71335-2075-5	Glycopyrrolate	100 in 1 BOTTLE	TABLET	100	102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2075	GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 5 package rows	20240531_bfccdb26-5047-4b54-9732-ffac2d78e4d1.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 · 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
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 ndc (product): 71335-2075
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
197738	glycopyrrolate 1 MG Oral Tablet	PSN	bfccdb26-5047-4b54-9732-ffac2d78e4d1	102
197738	glycopyrrolate 1 MG Oral Tablet	SCD	bfccdb26-5047-4b54-9732-ffac2d78e4d1	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2075-1	71335207501	30 TABLET in 1 BOTTLE (71335-2075-1)	30 tablet	2022-04-12	0000-00-00	No	No	Current
71335-2075-2	71335207502	270 TABLET in 1 BOTTLE (71335-2075-2)	270 tablet	2024-05-29	0000-00-00	No	No	Current
71335-2075-3	71335207503	28 TABLET in 1 BOTTLE (71335-2075-3)	28 tablet	2024-05-29	0000-00-00	No	No	Current
71335-2075-4	71335207504	90 TABLET in 1 BOTTLE (71335-2075-4)	90 tablet	2024-05-29	0000-00-00	No	No	Current
71335-2075-5	71335207505	100 TABLET in 1 BOTTLE (71335-2075-5)	100 tablet	2024-04-01		No	No	Current