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
4eab6184-1771-4c15-a127-4eb3e47affc2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-384
Application NumberANDA212968
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neostigmine methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 17, 2021
FDA Product Classification
INGREDIENTS (6)
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
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Neostigmine methylsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-383
Application NumberANDA212968
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neostigmine methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 17, 2021
FDA Product Classification
INGREDIENTS (6)
NEOSTIGMINE METHYLSULFATEActive
Quantity: 0.5 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
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT