Neostigmine Methylsulfate
These highlights do not include all the information needed to use Neostigmine Methylsulfate Injection safely and effectively. See full prescribing information for Neostigmine Methylsulfate Injection. Neostigmine Methylsulfate Injection, for intravenous use Initial U.S. Approval: 1939
Approved
Approval ID
11f38ea2-be55-4119-8eee-776f84c5e7f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2021
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
Products 2
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 Code65145-111
Application NumberANDA213074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neostigmine Methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 26, 2021
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 0.5 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Neostigmine Methylsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-112
Application NumberANDA213074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neostigmine Methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 26, 2021
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 1 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT