FDA.reportPublic FDA data

Neostigmine Methylsulfate

Product NDC
65219-811
11-digit product format
652190811
Labeler code
65219
Product ID
65219-811_0831f9a8-b6ff-4b49-91ad-8177f968f543
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
1 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 METHYLSULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui311936

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
65219-811-01Neostigmine Methylsulfate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
65219-811-10Neostigmine Methylsulfate10 in 1 TRAYINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-811-01ML - Milliliter65219-811f807ad7b-fbcd-46fb-820b-69beb8d3edaa12025-05-14
65219-811-10ML - Milliliter65219-811684663a7-182f-49e4-a2a1-b9ed83c6718a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-811NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20240127_088f96eb-20b8-48f8-ac83-329f75a44ce1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN088f96eb-20b8-48f8-ac83-329f75a44ce14
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD088f96eb-20b8-48f8-ac83-329f75a44ce14
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY088f96eb-20b8-48f8-ac83-329f75a44ce14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-811-016521908110110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
65219-811-106521908111010 VIAL, MULTI-DOSE in 1 TRAY (65219-811-10) / 10 mL in 1 VIAL, MULTI-DOSE (65219-811-01) 2023-01-090000-00-00NoNoCurrent