Glycopyrrolate

Product NDC: 50090-4522
11-digit product format: 500904522
Labeler code: 50090
Product ID: 50090-4522_206739b6-6349-43d8-9243-065de95584d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: A-S Medication Solutions
Application: ANDA208973
Marketing category: ANDA
Marketing start: 2017-06-15
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 0 mg/2mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	50090-4522		I	Inactivated by FDA		2026-08-10
excluded package	package	50090-4522	50090-4522-0	I	Inactivated by FDA		2026-08-10

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 · 30 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4522-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4522-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4522-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4522-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4522-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4522-0	`cdf11ea48f46…`	`ba0047e9e063…`
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	50090-4522-0	`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	50090-4522-0	`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	50090-4522-0	`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	50090-4522-0	`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	50090-4522-0	`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	50090-4522-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4522-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4522-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4522-0	`1332a3947898…`	`d4bfe170f9cd…`

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
A208973-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2017-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208973-001	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	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208973-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-06-15	`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	A208973-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208973-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208973-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208973-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208973-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208973-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208973-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208973-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208973-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208973-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208973-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208973-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208973-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208973-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208973-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208973-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208973-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208973-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208973-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208973-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208973-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208973-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208973-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208973-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208973-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208973-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208973-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208973-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208973-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208973-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208973-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208973-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208973-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208973-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208973-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208973-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208973-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208973-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208973-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208973-001	AP	1	`cb3db0bc1861…`

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
50090-4522-0	2023-01-30	C162847	48780-1	f386c64a-1b22-0266-e053-dadaa90a7c1a	Glycopyrrolate Injection, USP Rx only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4522-0	Glycopyrrolate	2 mL in 1 VIAL	INJECTION	2		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4522-0	ML - Milliliter	50090-4522	38fa1b2a-a9d6-4cad-9e6a-c3802c4deb0a	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4522	GLYCOPYRROLATE INJECTION [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20210417_55c9c26b-d08f-488f-a07c-c0dbb794a667.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Amneal Pharmaceuticals LLC	bbab4cf1-0441-4fc4-9de9-e4117fa19faa	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208973 application number: ANDA208973
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9a3a142c-daaf-79af-e053-2995a90a1c51	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208973 application number: ANDA208973
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	e8bb95ed-09f1-fcf1-e053-2a95a90a93e5	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208973 application number: ANDA208973

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
1731590	glycopyrrolate 0.4 MG in 2 ML Injection	PSN	55c9c26b-d08f-488f-a07c-c0dbb794a667	4
1731590	2 ML glycopyrrolate 0.2 MG/ML Injection	SCD	55c9c26b-d08f-488f-a07c-c0dbb794a667	4
1731590	glycopyrrolate 0.4 MG per 2 ML Injection	SY	55c9c26b-d08f-488f-a07c-c0dbb794a667	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4522-0	50090452200	2 mL in 1 VIAL (50090-4522-0)	2 ml	2019-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate Injection, USP Rx only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	4