FDA.reportPublic FDA data

NDC 76045-203-01 - 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
76045-203
Requested NDC
76045-203-01
Package NDCs from labels
76045-203-01, 76045-203-10, 76045-203-02, 76045-203-20
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
76045-203-01Glycopyrrolate1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION18
76045-203-01Glycopyrrolate1 in 1 BLISTER PACKINJECTION, SOLUTION18
76045-203-02Glycopyrrolate2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION28
76045-203-02Glycopyrrolate1 in 1 BLISTER PACKINJECTION, SOLUTION18
76045-203-10Glycopyrrolate24 in 1 CARTONINJECTION, SOLUTION248
76045-203-20Glycopyrrolate24 in 1 CARTONINJECTION, SOLUTION248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-203GLYCOPYRROLATE (GLYCOPYRROLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 6 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
76045-203-01ML - Milliliter76045-2031191713f-0450-4d28-a839-019a5e95453d12019-04-11
76045-203-02ML - Milliliter76045-203b2e59ec7-1baa-47fa-9d56-70141e52520912019-04-11
76045-203-10ML - Milliliter76045-203c7de88ad-2b9e-4c5f-a0f9-ac8712526ae112019-04-11
76045-203-20ML - Milliliter76045-203ced4ce01-f0f2-467e-801b-3445a4206c6d12019-04-11

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 16 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEAlembic Labs LLCdb178372-51d2-4194-bbe2-da9acb1cfd532020-12-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATECivica, Inc.9f7f1ebf-58e8-4ae7-8157-1595df8ad6f42020-02-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEDr. Reddy's Laboratories Limited725529e8-9c4b-4108-690a-e4f3914397362016-11-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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