Bloxiverz
These highlights do not include all the information needed to use BLOXIVERZ safely and effectively. See full prescribing information for BLOXIVERZ. BLOXIVERZ (Neostigmine Methylsulfate Injection), for intravenous use Initial U.S. Approval: 1939
Approved
Approval ID
d2f55643-2b0d-4ef9-a9d8-b7138b314372
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
Products 3
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 Code51754-1220
Application NumberNDA204078
Product Classification
M
Marketing Category
C73594
G
Generic Name
Neostigmine Methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Quantity: 4.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 1 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Neostigmine Methylsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-1200
Application NumberNDA204078
Product Classification
M
Marketing Category
C73594
G
Generic Name
Neostigmine Methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 90 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: CNTM
NEOSTIGMINE METHYLSULFATEActive
Quantity: 1 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 1 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
Neostigmine Methylsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-1210
Application NumberNDA204078
Product Classification
M
Marketing Category
C73594
G
Generic Name
Neostigmine Methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Quantity: 4.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 0.5 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT