Glycopyrrolate

Product NDC: 50090-6113
Requested package NDC: 50090-6113-0
11-digit product format: 500906113
Labeler code: 50090
Product ID: 50090-6113_b0da9368-5f22-4fc1-a2ca-cb3cd2feb41b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glycopyrrolate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: A-S Medication Solutions
Application: ANDA213238
Marketing category: ANDA
Marketing start: 2020-12-17
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 0 mg/mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-6113	50090-6113-0	I	Inactivated by FDA		2026-08-17

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 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213238-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2020-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213238-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213238-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-07-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213238-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213238-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213238-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213238-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213238-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213238-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213238-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213238-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213238-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213238-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213238-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213238-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213238-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213238-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213238-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213238-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213238-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213238-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213238-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213238-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213238-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213238-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213238-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213238-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213238-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213238-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213238-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213238-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213238-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213238-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213238-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213238-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213238-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213238-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213238-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213238-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213238-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213238-001	AP	1	`a50c72e98297…`

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-6113-0	2024-01-30	C162847	48780-1	1030e365-5f87-111a-e063-dadaa90a10e2	Glycopyrrolate injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6113-0	Glycopyrrolate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1		2
50090-6113-0	Glycopyrrolate	1 in 1 CARTON	INJECTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6113-0	ML - Milliliter	50090-6113	558b6cf9-186f-4a80-b14c-1de0789413b1	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6113	GLYCOPYRROLATE INJECTION [A-S MEDICATION SOLUTIONS]	2	Legacy NDC, 2 package rows	20221007_31f0e708-fb96-49d1-98c5-3a2026ee7e83.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Accord Healthcare, Inc.,	871797f0-697a-4a29-a37b-d06219e8f266	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213238 application number: ANDA213238
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	bbf0abe2-8deb-19b2-e053-2a95a90a60a3	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213238 application number: ANDA213238

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
1731582	glycopyrrolate 0.2 MG in 1 ML Injection	PSN	31f0e708-fb96-49d1-98c5-3a2026ee7e83	2
1731582	1 ML glycopyrrolate 0.2 MG/ML Injection	SCD	31f0e708-fb96-49d1-98c5-3a2026ee7e83	2
1731582	glycopyrrolate 0.2 MG per 1 ML Injection	SY	31f0e708-fb96-49d1-98c5-3a2026ee7e83	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6113-0	50090611300	1 VIAL, SINGLE-DOSE in 1 CARTON (50090-6113-0) > 1 mL in 1 VIAL, SINGLE-DOSE	2022-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate injection, USP	A-S Medication Solutions	2022-10-06	HUMAN PRESCRIPTION DRUG LABEL	2