Glycopyrrolate

Product NDC
71872-7227
11-digit product format
718727227
Labeler code
71872
Product ID
71872-7227_fae67b9a-7ddb-3840-e053-6294a90a9c56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA210246
Marketing category
ANDA
Marketing start
2020-06-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71872-7227EExcluded after deficient or non-compliant submission was not corrected2026-09-14
excluded packagepackage71872-722771872-7227-1EExcluded after deficient or non-compliant submission was not corrected2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210246-001GLYCOPYRROLATEGLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTION2019-10-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTION2019-10-2984e616aacf4f…
2026-08-18 06:07:402026-07A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTION2019-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTION2019-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-293f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210246-001GLYCOPYRROLATE0.2MG/MLINJECTABLE / INJECTIONAP2019-10-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210246-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210246-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210246-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210246-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210246-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210246-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210246-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210246-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210246-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210246-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210246-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210246-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210246-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210246-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210246-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210246-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210246-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210246-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210246-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210246-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A210246-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210246-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210246-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210246-001AP13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210246-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210246-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210246-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210246-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210246-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210246-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210246-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210246-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210246-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210246-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210246-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210246-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210246-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
138c3de2-4b03-4255-92b5-f022482d81bcProduct name420260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810eProduct name520250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7227-1Glycopyrrolate1 in 1 BAGINJECTION12
71872-7227-1Glycopyrrolate1 mL in 1 VIALINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7227GLYCOPYRROLATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230505_b634a7da-fc13-194c-e053-2995a90a081c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNb634a7da-fc13-194c-e053-2995a90a081c2
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDb634a7da-fc13-194c-e053-2995a90a081c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7227-1718727227011 VIAL in 1 BAG (71872-7227-1) / 1 mL in 1 VIAL1 vial2020-09-250000-00-00NoNoCurrent