Glycopyrrolate

Product NDC: 0641-6036
11-digit product format: 006416036
Labeler code: 0641
Product ID: 0641-6036_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: West-ward Pharmaceutical Corp.
Application: NDA017558
Marketing category: NDA
Marketing start: 1975-02-06
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 0 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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	0641-6036		D	Discontinued by firm		2026-08-10
excluded package	package	0641-6036	0641-6036-10	D	Discontinued by firm		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 · 44 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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`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	0641-6036-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0641-6036-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0641-6036-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0641-6036-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0641-6036-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0641-6036-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0641-6036-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0641-6036-10	`110d247fa046…`	`a55b01930146…`

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
N017558-001	ROBINUL	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017558-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017558-001	ROBINUL	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017558-001	ROBINUL	0.2MG/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017558-001	ROBINUL	0.2MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017558-001	ROBINUL	0.2MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017558-001	ROBINUL	0.2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017558-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017558-001	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017558-001	AP	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0641-6036-10	2019-11-13	C162847	48780-1	97449f38-ba6e-f6ea-e053-dbdaa90aa703	Glycopyrrolate Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6036-01	ML - Milliliter	0641-6036	2648b90f-077a-457e-aed8-ac0a34112c8a	1	2013-02-13
0641-6036-10	ML - Milliliter	0641-6036	e30a9072-2888-4305-adfe-073a58de6e73	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCOPYRROLATE	ACTIVE INGREDIENT	V92SO9WP2I	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3
GLYCOPYRROLATE	ACTIVE MOIETY	V92SO9WP2I	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6036	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3	Legacy NDC	20120612_61767a0d-c94c-44d8-b35c-316a5731a275.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	960d2dd0-008d-4ec1-ba2e-9388b28b23e2	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017558 application number: NDA017558

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V92SO9WP2I	GLYCOPYRROLATE	51186-83-5	GLYCOPYRROLATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate Injection, USP	West-ward Pharmaceutical Corp.	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	3