FDA.reportPublic FDA data

NDC 68083-377-01 - 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
68083-377
Requested NDC
68083-377-01
Package NDCs from labels
68083-377-01, 68083-377-25
Manufacturer
Gland Pharma Limited
Effective date
2026-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - Gland Pharma LimitedGland Pharma Limited2026-04-28Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-377-01Glycopyrrolate2 mL in 1 VIALINJECTION26
68083-377-25Glycopyrrolate25 in 1 CARTONINJECTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-377GLYCOPYRROLATE INJECTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20221012_d670bd26-8a44-44be-90e1-107d4c380233.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 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f12016d-9033-00b4-e053-2a95a90ad02a2023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9c9666bf-841b-03fa-e053-2a95a90abb482023-05-11Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9e5113b7-1c0c-24bd-e053-2995a90ab94b2023-05-09Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCbbf0abe2-8deb-19b2-e053-2a95a90a60a32023-05-08Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCb622f21f-fa37-1259-e053-2995a90aa7962023-05-04Warnings, Adverse reactionsExact identifier
application number: ANDA212612
rxcui: 1731582
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEMedical Purchasing Solutions, LLCa2a2a03f-21cc-5fec-e053-2995a90a84cb2023-05-03Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
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
application number: ANDA212612
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
NOVOLOGINSULIN ASPARTNovo 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

Reported adverse events (FAERS/openFDA)#

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