Glycopyrrolate

Product NDC: 71872-7196
Requested package NDC: 71872-7196-1
11-digit product format: 718727196
Labeler code: 71872
Product ID: 71872-7196_fb4bf45a-8a5f-2abc-e053-6294a90a12cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: ANDA210842
Marketing category: ANDA
Marketing start: 2019-07-11
Substance: GLYCOPYRROLATE
Active strength: .2 mg/mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210842-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2018-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210842-001	AP

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 2 · 41 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	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210842-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2018-10-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A210842-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210842-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210842-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210842-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210842-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210842-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210842-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210842-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210842-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210842-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210842-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210842-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210842-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210842-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210842-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210842-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210842-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210842-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210842-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210842-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210842-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210842-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210842-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210842-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210842-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210842-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210842-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210842-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210842-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210842-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210842-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210842-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210842-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210842-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210842-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210842-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210842-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210842-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210842-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210842-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCOPYRROLATE	.2 mg/mL

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
238212	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
9e5113b7-1c0c-24bd-e053-2995a90ab94b	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
71872-7196-1	Glycopyrrolate	5 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	5		2
71872-7196-1	Glycopyrrolate	1 in 1 BAG	INJECTION, SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71872-7196	GLYCOPYRROLATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230510_9e5113b7-1c0c-24bd-e053-2995a90ab94b.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Piramal Critical Care Inc	83d70378-011b-4ce3-e053-2991aa0a22be	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	430635e8-7c9e-77f6-e063-6294a90a4c8a	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	83602e34-7a8c-4606-b43e-23ab909b6c1a	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	74d51ba3-0ca0-4a04-aa87-1c243f885bd8	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	4ecb3435-58e5-46cb-b8c2-85b5fd955f83	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3f2b4281-55f3-43e3-e063-6294a90a56ba	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	ProPharma Distribution	3edd6a26-dd0f-2411-e063-6394a90affa2	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f126596-7fbf-7a48-e053-2995a90abac7	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f12016d-9033-00b4-e053-2a95a90ad02a	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210842 application number: ANDA210842 ndc (package): 71872-7196-1 ndc (product): 71872-7196 ndc11 (package): 71872719601

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
238212	glycopyrrolate 0.2 MG/ML Injectable Solution	PSN	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2
238212	glycopyrrolate 0.2 MG/ML Injectable Solution	SCD	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71872-7196-1	71872719601	1 VIAL, GLASS in 1 BAG (71872-7196-1) / 5 mL in 1 VIAL, GLASS	2020-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx ONLY NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL	Medical Purchasing Solutions, LLC	2023-05-09	HUMAN PRESCRIPTION DRUG LABEL	2