Glycopyrrolate

Product NDC: 63323-578
11-digit product format: 633230578
Labeler code: 63323
Product ID: 63323-578_779dc924-ecc3-41cc-8cf9-a7354db4f763
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA209328
Marketing category: ANDA
Marketing start: 2017-10-27
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

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	63323-578	63323-578-20	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 · 12 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…`

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
A209328-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2017-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209328-001	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	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209328-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2017-10-27	`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	A209328-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209328-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209328-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209328-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209328-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209328-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209328-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209328-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209328-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209328-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209328-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209328-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209328-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209328-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209328-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209328-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209328-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209328-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209328-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209328-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209328-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209328-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209328-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209328-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209328-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209328-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209328-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209328-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209328-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209328-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209328-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209328-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209328-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209328-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209328-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209328-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209328-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209328-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209328-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209328-001	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238212	Internal RxNorm lookup
1731582	Internal RxNorm lookup
1731590	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
54458620-d888-4df6-ae4b-78c3dfed3423	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
63323-578-01	Glycopyrrolate	25 in 1 CARTON	INJECTION, SOLUTION	25	4
63323-578-02	Glycopyrrolate	25 in 1 CARTON	INJECTION, SOLUTION	25	4
63323-578-03	Glycopyrrolate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1	4
63323-578-04	Glycopyrrolate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	4
63323-578-05	Glycopyrrolate	25 in 1 CARTON	INJECTION, SOLUTION	25	4
63323-578-07	Glycopyrrolate	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	4
63323-578-18	Glycopyrrolate	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	4
63323-578-20	Glycopyrrolate	10 in 1 CARTON	INJECTION, SOLUTION	10	4
63323-578-11	Glycopyrrolate	25 in 1 CARTON	INJECTION, SOLUTION	25	3
63323-578-12	Glycopyrrolate	25 in 1 CARTON	INJECTION, SOLUTION	25	3
63323-578-41	Glycopyrrolate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1	3
63323-578-42	Glycopyrrolate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-578-01	ML - Milliliter	63323-578	b7f46d2f-ea2f-4330-96a8-56c6ef7c4b22	1	2018-07-03
63323-578-02	ML - Milliliter	63323-578	7d9a2c08-fb62-4dcd-b18b-63a5640061e6	1	2018-07-03
63323-578-03	ML - Milliliter	63323-578	5929dd36-ff2b-4f07-9c09-8be417890980	1	2018-07-03
63323-578-04	ML - Milliliter	63323-578	2c6613c3-f80c-4f14-b899-e82c58f75d37	1	2018-07-03
63323-578-05	ML - Milliliter	63323-578	949ab91e-7e51-4d31-b454-0293f4b61605	1	2018-07-03
63323-578-07	ML - Milliliter	63323-578	de4b034d-1017-46cb-bd27-b4d33cc3b391	1	2018-07-03
63323-578-11	ML - Milliliter	63323-578	2e2cba68-a76c-48fe-99bd-30eba7b3818c	1	2018-08-13
63323-578-12	ML - Milliliter	63323-578	81049050-8f1a-4f04-8bdb-28a99f620c3c	1	2018-08-13
63323-578-18	ML - Milliliter	63323-578	37b81f3c-b5ec-4597-a0b1-7866cf8e7757	1	2018-07-03
63323-578-20	ML - Milliliter	63323-578	0ba83fa3-b05c-4dfa-bc69-2b90b55ad507	1	2018-07-03
63323-578-41	ML - Milliliter	63323-578	01554d58-69a7-4ab1-a7fc-987b83cb23e7	1	2018-09-05
63323-578-42	ML - Milliliter	63323-578	6b90b701-7219-4371-bece-0701915749fb	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-578	GLYCOPYRROLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 8 package rows	20230825_54458620-d888-4df6-ae4b-78c3dfed3423.zip
63323-578	GLYCOPYRROLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 4 package rows	20241019_ccafb5c2-86dd-4bb2-883a-c13e3171227c.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	Fresenius Kabi USA, LLC	ccafb5c2-86dd-4bb2-883a-c13e3171227c	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209328 application number: ANDA209328 ndc (product): 63323-578
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	250eeef7-b1a9-45e7-a927-7807232e10be	2023-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209328 application number: ANDA209328
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	54458620-d888-4df6-ae4b-78c3dfed3423	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209328 application number: ANDA209328 ndc (product): 63323-578

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	54458620-d888-4df6-ae4b-78c3dfed3423	4
238212	glycopyrrolate 0.2 MG/ML Injectable Solution	PSN	54458620-d888-4df6-ae4b-78c3dfed3423	4
1731590	glycopyrrolate 0.4 MG in 2 ML Injection	PSN	54458620-d888-4df6-ae4b-78c3dfed3423	4
1731582	1 ML glycopyrrolate 0.2 MG/ML Injection	SCD	54458620-d888-4df6-ae4b-78c3dfed3423	4
1731590	2 ML glycopyrrolate 0.2 MG/ML Injection	SCD	54458620-d888-4df6-ae4b-78c3dfed3423	4
238212	glycopyrrolate 0.2 MG/ML Injectable Solution	SCD	54458620-d888-4df6-ae4b-78c3dfed3423	4
1731582	glycopyrrolate 0.2 MG per 1 ML Injection	SY	54458620-d888-4df6-ae4b-78c3dfed3423	4
1731590	glycopyrrolate 0.4 MG per 2 ML Injection	SY	54458620-d888-4df6-ae4b-78c3dfed3423	4
1731582	glycopyrrolate 0.2 MG in 1 ML Injection	PSN	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
238212	glycopyrrolate 0.2 MG/ML Injectable Solution	PSN	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
1731590	glycopyrrolate 0.4 MG in 2 ML Injection	PSN	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
1731582	1 ML glycopyrrolate 0.2 MG/ML Injection	SCD	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
1731590	2 ML glycopyrrolate 0.2 MG/ML Injection	SCD	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
238212	glycopyrrolate 0.2 MG/ML Injectable Solution	SCD	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
1731582	glycopyrrolate 0.2 MG per 1 ML Injection	SY	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3
1731590	glycopyrrolate 0.4 MG per 2 ML Injection	SY	ccafb5c2-86dd-4bb2-883a-c13e3171227c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-578-01	63323057801	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)		2017-10-27	0000-00-00	No	No	Current
63323-578-02	63323057802	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04)		2017-10-27	0000-00-00	No	No	Current
63323-578-03	63323057803	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-578-04	63323057804	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
63323-578-05	63323057805	25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07)		2017-10-27	0000-00-00	No	No	Current
63323-578-07	63323057807	5 mL in 1 VIAL, MULTI-DOSE	5 ml					Historical
63323-578-11	63323057811	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-11) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-41)		2017-10-27	0000-00-00	No	No	Current
63323-578-12	63323057812	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-42)		2017-10-27	0000-00-00	No	No	Current
63323-578-18	63323057818	20 mL in 1 VIAL, MULTI-DOSE	20 ml					Historical
63323-578-20	63323057820	10 VIAL, MULTI-DOSE in 1 CARTON (63323-578-20) > 20 mL in 1 VIAL, MULTI-DOSE (63323-578-18)		2017-10-27	0000-00-00	No	No	Current
63323-578-41	63323057841	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-578-42	63323057842	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate Injection, USP	Fresenius Kabi USA, LLC	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	3
Glycopyrrolate Injection, USP	Fresenius Kabi USA, LLC	2023-08-16	Human Prescription Drug Label	4