Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Exela Pharma Sciences, LLC
Exela Pharma Sciences, LLC
831274399
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bloxiverz
Product Details
NDC Product Code
51754-1220Application Number
NDA204078Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 31, 2023PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 4.5 mg in 1 mL
NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 1 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Bloxiverz
Product Details
NDC Product Code
51754-1200Application Number
NDA204078Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 31, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 90 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Acetic acidInactive
Code: Q40Q9N063PClass: CNTM
NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 1 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 1 mg in 1 mL
Sodium hydroxideInactive
Code: 55X04QC32IClass: CNTM
Bloxiverz
Product Details
NDC Product Code
51754-1210Application Number
NDA204078Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
December 31, 2023PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 4.5 mg in 1 mL
NeostigmineActive
Code: 98IMH7M386Class: ACTIBQuantity: 0.5 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT