FDA.reportPublic FDA data

NDC 65145-103-01 - Glycopyrrolate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65145-103
Requested NDC
65145-103-01
Package NDCs from labels
65145-103-01, 65145-103-25
Manufacturer
Caplin Steriles Limited
Effective date
2025-01-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - Caplin Steriles LimitedCaplin Steriles Limited2025-01-25Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-103-01Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION25
65145-103-25Glycopyrrolate25 in 1 CARTONINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-103GLYCOPYRROLATE INJECTION [CAPLIN STERILES LIMITED]5Current NDC, Legacy NDC, 2 package rows20250126_765490fa-8378-40c8-9fa7-b0bfa2e1a0a9.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 15 of 17 · 330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATELGM PHARMA SOLUTIONS, LLC392a969d-1e14-4ad8-835c-a47be49830672023-04-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCe8bb95ed-09f1-fcf1-e053-2a95a90a93e52023-04-25Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCea4c8be4-a1e9-5901-e053-2995a90a5e632023-04-24Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BEVESPI AEROSPHEREGLYCOPYRROLATE AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LPae02436e-9528-490e-a844-0c0f6f2843f92023-03-24Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATECivica, Inc.3ac4f32f-f5ca-4a6d-9bc7-2672d478b3d42023-03-01Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
GlycopyrrolateGLYCOPYRROLATEMeitheal Pharmaceuticals Inc.02f914a8-2356-4525-91ff-cf0c9e41ba232023-01-12Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
GLYCOPYRROLATEGLYCOPYRROLATEQuinn Pharmaceuticalse1ded8e0-c05b-4bf4-a129-57d1726af6ed2022-12-20Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.26cdd84d-ffa0-4e52-b359-4acef4bd80932022-11-10Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATECamber Pharmaceuticals, Inc.4741be85-3abb-4545-aba9-281f64d210ec2022-07-13Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GLYCOPYRROLATEGLYCOPYRROLATENovadoz Pharmaceuticals LLC98820c01-1853-45d8-9da5-875fcdf5f9ab2022-06-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.