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
2025-11-30
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, LLC2025-11-30HUMAN 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 5 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEAurolife Pharma LLC677f8495-a870-45b6-bb65-75b449f040ce2025-12-11Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEChartwell RX, LLC5773cf63-4006-4d8f-b53b-c84bcfe19e4a2025-12-10Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATERising Pharma Holdings, Inc.58c4cb1f-59b8-4be9-a222-2264ca077d932025-12-03Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC2972f22e-378c-450b-8869-1354a9bd0ffc2025-11-30Warnings, Adverse reactionsExact identifier
application number: ANDA210927
ndc (package): 43547-639-25
ndc (package): 43547-640-01
ndc (package): 43547-639-01
ndc (package): 43547-640-25
ndc (product): 43547-640
ndc (product): 43547-639
ndc11 (package): 43547064001
rxcui: 1731582
rxcui: 1731590
spl id: 8a403c54-3e23-41fc-bf80-c40e8d867aa2
spl set id: 2972f22e-378c-450b-8869-1354a9bd0ffc
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC3707f06a-6cba-4f5c-86ab-fb95bc2a933c2025-11-30Warnings, Adverse reactionsExact identifier
application number: ANDA210927
rxcui: 1731582
rxcui: 1731590
unii: V92SO9WP2I
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution430635e8-7c9e-77f6-e063-6294a90a4c8a2025-11-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.83602e34-7a8c-4606-b43e-23ab909b6c1a2025-11-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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