Neostigmine Methylsulfate
Approved
Approval ID
454d54dc-b803-4519-81e8-ac7d21e6aae1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neostigmine Methylsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-462
Application NumberANDA207042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neostigmine Methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (6)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 1 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
PHENOLInactive
Quantity: 4.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT