FDA.reportPublic FDA data

NDC 0517-4601-01 - 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
0517-4601
Requested NDC
0517-4601-01
Package NDCs from labels
0517-4601-01, 0517-4601-25
Manufacturer
American Regent, Inc.
Effective date
2024-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLYCOPYRROLATE INJECTION, USPAmerican Regent, Inc.2024-02-07HUMAN PRESCRIPTION DRUG LABEL
Glycopyrrolate - Cardinal HealthCardinal Health2019-09-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-4601-25Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION111
0517-4601-25Glycopyrrolate25 in 1 TRAYINJECTION, SOLUTION2511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-4601GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]11Current NDC, Legacy NDC, 2 package rows20240208_62267afe-1a73-4623-984e-646db590ec5b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-4601-25ML - Milliliter0517-4601a9213cd6-593f-4b41-bd86-98c15c66fde812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH]3
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH]3
waterINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH]3

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 9 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
glycopyrrolateGLYCOPYRROLATESaptalis Pharmaceuticals, LLC.3e6f8091-d6fe-4c8f-b897-606a70bf74bc2024-11-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLCccafb5c2-86dd-4bb2-883a-c13e3171227c2024-10-14Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack987ba524-361e-49c3-9e00-550a787485422024-10-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack48a8356e-377e-45ef-a1bf-e9ffec0517492024-10-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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