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 6 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
TopCare Cherry FlavorPHENOLTOPCO ASSOCIATES, LLC5d3f0610-deb4-4180-ae19-2c65ed2f368b2025-11-10WarningsExact identifier
unii: 339NCG44TV
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
unii: 339NCG44TV
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Castellani PaintPHENOLStratus Pharamceuticals74192c0e-3c73-4ab0-96d1-1917cbd6777a2025-10-30WarningsExact identifier
unii: 339NCG44TV
SKIN TAG REMOVERSALICYLIC ACIDShenzhen Yaozhihong Technology Co., Ltd.4246d4d5-9955-ba5a-e063-6394a90a84482025-10-29WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
unii: 339NCG44TV
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
unii: 339NCG44TV
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
unii: 339NCG44TV
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
unii: 339NCG44TV
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sore Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact identifier
unii: 339NCG44TV
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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