FDA.reportPublic FDA data

Neostigmine Methylsulfate

Product NDC
63323-413
11-digit product format
633230413
Labeler code
63323
Product ID
63323-413_1efedce1-b2c3-4652-a289-6ea596b039e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine Methylsulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA203629
Marketing category
NDA
Marketing start
2015-01-08
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
.5 mg/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neostigmine Methylsulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui311935, 311936

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
6c2b16d0-96e9-444e-98c5-9883cd6eb72dProduct name220230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ad279e69-d021-f6bd-1150-2b55f23832d5Product name920211014
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN6448229c-e650-47ba-bb00-cba3604502c54
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN6448229c-e650-47ba-bb00-cba3604502c54
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD6448229c-e650-47ba-bb00-cba3604502c54
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD6448229c-e650-47ba-bb00-cba3604502c54
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY6448229c-e650-47ba-bb00-cba3604502c54
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY6448229c-e650-47ba-bb00-cba3604502c54
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSNd0e11e4c-41c3-4874-b567-579db655fba33
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSNd0e11e4c-41c3-4874-b567-579db655fba33
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCDd0e11e4c-41c3-4874-b567-579db655fba33
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCDd0e11e4c-41c3-4874-b567-579db655fba33
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSYd0e11e4c-41c3-4874-b567-579db655fba33
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSYd0e11e4c-41c3-4874-b567-579db655fba33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-413-016332304130110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
63323-413-106332304131010 VIAL, MULTI-DOSE in 1 TRAY (63323-413-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-413-01) 2015-01-080000-00-00NoNoCurrent
63323-413-366332304133610 VIAL, MULTI-DOSE in 1 TRAY (63323-413-36) / 10 mL in 1 VIAL, MULTI-DOSE2015-01-080000-00-00NoNoCurrent