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 2 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEPiramal Critical Care Inc83d70378-011b-4ce3-e053-2991aa0a22be2026-06-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATECardinal Health 107, LLC65688bed-0d70-4b51-8301-1948b1deade12026-06-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEREMEDYREPACK INC.220cd5f5-3d71-4fdb-9943-7468799c179f2026-06-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEGolden State Medical Supply, Inc.ec15e70c-8473-469a-9f07-ea668783fa072026-05-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMeitheal Pharmaceuticals Inc.02541cfd-b209-49b9-a73f-13ef18dce06d2026-05-20Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLCff65c5d3-7ba9-4315-a884-199151eb45a52026-05-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack098c7654-a352-47ee-bf23-6a81f86012662026-05-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAtlantic Biologicals Corp.50b493d7-8e3b-e459-e063-6394a90addbc2026-04-30Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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