FDA.reportPublic FDA data

NDC 63323-413-01 - Neostigmine Methylsulfate

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
63323-413
Requested NDC
63323-413-01
Package NDCs from labels
63323-413-36, 63323-413-01, 63323-413-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neostigmine Methylsulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-15HUMAN PRESCRIPTION DRUG LABEL
Neostigmine Methylsulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-12-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-413-01Neostigmine Methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
63323-413-10Neostigmine Methylsulfate10 in 1 TRAYINJECTION, SOLUTION104
63323-413-36Neostigmine Methylsulfate10 in 1 TRAYINJECTION, SOLUTION103
63323-413-36Neostigmine Methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-413NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20221217_6448229c-e650-47ba-bb00-cba3604502c5.zip
63323-413NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20241020_d0e11e4c-41c3-4874-b567-579db655fba3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-413-10ML - Milliliter63323-4136a6ee13a-ac87-45ce-bdf7-6cbc5358277112015-03-03
63323-413-36ML - Milliliter63323-413259824c1-d243-4db2-a3e2-36e20fbbe8cd12016-08-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOSTIGMINE METHYLSULFATEACTIVE INGREDIENT98IMH7M386NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
NEOSTIGMINE METHYLSULFATEACTIVE INGREDIENT98IMH7M386NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
NEOSTIGMINEACTIVE MOIETY3982TWQ96GNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
NEOSTIGMINEACTIVE MOIETY3982TWQ96GNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PHENOLINACTIVE INGREDIENT339NCG44TVNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PHENOLINACTIVE INGREDIENT339NCG44TVNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BNEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 20 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Acetic AcidACETIC ACIDBaxter Healthcare Corporation41bc12af-fac5-4ac1-b907-dcb3e35a054c2018-02-02Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: Q40Q9N063P
Glucose Control T015SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMGuangzhou Renuma Medical Systems Co., Ltd3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b2017-10-26WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Camphor Phenol GelCAMPHOR, PHENOLWalgreens8e992180-ca87-4aba-9689-82263561b3922017-08-31WarningsExact identifier
unii: 339NCG44TV
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
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.