FDA.reportPublic FDA data

NDC 43547-640-01 - 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
43547-640
Requested NDC
43547-640-01
Package NDCs from labels
43547-640-01, 43547-640-25
Manufacturer
Solco Healthcare US, LLC
Effective date
2026-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLYCOPYRROLATE - Solco Healthcare US, LLCSolco Healthcare US, LLC2026-07-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-640-01GLYCOPYRROLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION23
43547-640-25GLYCOPYRROLATE25 in 1 CARTONINJECTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-640GLYCOPYRROLATE INJECTION [SOLCO HEALTHCARE US, LLC]1Current NDC, Legacy NDC, 2 package rows20210903_2972f22e-378c-450b-8869-1354a9bd0ffc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-640-01ML - Milliliter43547-64049f81f6b-e54b-494e-8190-260a1fc971a112021-10-08
43547-640-25ML - Milliliter43547-64092a440e9-2272-445c-ab29-052300c3886312021-10-08

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 14 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCb622f21f-fa37-1259-e053-2995a90aa7962023-05-04Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEMedical Purchasing Solutions, LLCa2a2a03f-21cc-5fec-e053-2995a90a84cb2023-05-03Warnings, Adverse reactionsExact identifier
application number: ANDA210927
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
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCea4c8be4-a1e9-5901-e053-2995a90a5e632023-04-24Warnings, Adverse reactionsExact identifier
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
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

Reported adverse events (FAERS/openFDA)#

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