FDA.reportPublic FDA data

NDC 76045-206-01 - 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
76045-206
Requested NDC
76045-206-01
Package NDCs from labels
76045-206-01, 76045-206-10
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi, USA LLC
Effective date
2023-08-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - Fresenius Kabi USA, LLC | Fresenius Kabi, USA LLCFresenius Kabi USA, LLC | Fresenius Kabi, USA LLC2023-08-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-206-01Glycopyrrolate1 in 1 BLISTER PACKINJECTION, SOLUTION18
76045-206-01Glycopyrrolate1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION18
76045-206-10Glycopyrrolate24 in 1 CARTONINJECTION, SOLUTION248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-206GLYCOPYRROLATE (GLYCOPYRROLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 3 package rows20230825_88d3e865-8dca-4c89-b6f7-a34c481f75b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-206-01ML - Milliliter76045-206054970c9-c10d-4526-8e52-e07527f686b912021-09-07
76045-206-10ML - Milliliter76045-20609907e3d-cd2d-4526-8421-ecb8c1469e1112021-09-07

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
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC3707f06a-6cba-4f5c-86ab-fb95bc2a933c2025-11-30Warnings, Adverse reactionsExact identifier
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.