NDC Code(s) : 67457-571-00, 67457-571-10, 67457-572-00, 67457-572-20
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VECURONIUM BROMIDEVECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-571
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VECURONIUM BROMIDE(UNII: 7E4PHP5N1D)
(VECURONIUM - UNII:5438723848) 		VECURONIUM BROMIDE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PHOSPHORIC ACID(UNII: E4GA8884NN)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-571-1010 in 1 CARTON 02/12/2014
1NDC:67457-571-0010 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090243 05/11/2011
VECURONIUM BROMIDEVECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-572
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VECURONIUM BROMIDE(UNII: 7E4PHP5N1D)
(VECURONIUM - UNII:5438723848) 		VECURONIUM BROMIDE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PHOSPHORIC ACID(UNII: E4GA8884NN)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-572-2010 in 1 CARTON 22/01/2015
1NDC:67457-572-0020 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090243 05/11/2011

PRINCIPAL DISPLAY PANEL

NDC 67457-571-10

Rx ONLY

Contains 10 of NDC 67457-571-00

Vecuronium Bromide for Injection

Lyophilized Powder

*1 mg/mL when reconstituted to 10 mL

For IV Single Use Only

10 x 10 mg Single-Use Vials

10 mg*

NOVAPLUS

10 mg carton

PRINCIPAL DISPLAY PANEL

NDC 67457-572-20

Rx ONLY

Contains 10 of NDC 67457-572-00

Vecuronium Bromide for Injection

Lyophilized Powder

*1 mg/mL when reconstituted to 20 mL

For IV Single Use Only

10 x 20 mg Single-Use Vials

20 mg*

NOVAPLUS

20 mg carton