Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Apitoria Pharma Private Limited
Eugia US LLC
918917662
Eugia Pharma Specialities Limited
Eugia US LLC
650498244
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEOSTIGMINE METHYLSULFATE
Product Details
NDC Product Code
55150-348Application Number
ANDA213244Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 2, 2023PHENOLInactive
Code: 339NCG44TVClass: IACT
NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 0.5 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
NEOSTIGMINE METHYLSULFATE
Product Details
NDC Product Code
55150-349Application Number
ANDA213244Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 2, 2023PHENOLInactive
Code: 339NCG44TVClass: IACT
NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT