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
5a01a429-a346-4253-8994-b58d34b57974
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2021
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-500
Application NumberANDA212804
Product Classification
M
Marketing Category
C73584
G
Generic Name
neostigmine methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Quantity: 4.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NEOSTIGMINE METHYLSULFATEActive
Quantity: 0.51 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
neostigmine methylsulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-501
Application NumberANDA212804
Product Classification
M
Marketing Category
C73584
G
Generic Name
neostigmine methylsulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (6)
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
NEOSTIGMINE METHYLSULFATEActive
Quantity: 1.02 mg in 1 mL
Code: 98IMH7M386
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT