NDC Code(s) : 0069-0094-01, 0069-0094-02, 0069-0108-04, 0069-0108-05
Packager : Pfizer Laboratories Div Pfizer Inc

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:0069-0094
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)20.75 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)16.25 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)97 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PHOSPHORIC ACID(UNII: E4GA8884NN)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0094-0210 in 1 CARTON
1NDC:0069-0094-011 mL in 1 VIAL
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:0069-0108
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)41.5 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)32.5 mg in 1 mL
MANNITOL(UNII: 3OWL53L36A)194 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PHOSPHORIC ACID(UNII: E4GA8884NN)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0108-0510 in 1 CARTON
1NDC:0069-0108-041 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090243 05/11/2011

PRINCIPAL DISPLAY PANEL

NDC 0069-0094-01

Vecuronium
Bromide for
Injection
10 mg*

For IV Use Only
*1 mg/mL when
reconstituted to 10 mL

Rx only

PRINCIPAL DISPLAY PANEL - 10 mg Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0094-02
Contains 10 of NDC 0069-0094-01

10 x 10 mg Single-Use Vials
Rx only

Vecuronium Bromide
for Injection
10 mg*

Lyophilized Powder
For IV Single Use Only

*1 mg/mL when reconstituted to 10 mL

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 10 mg Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-0108-04

Vecuronium
Bromide for
Injection
20 mg*

For IV Use Only
*1 mg/mL when
reconstituted to 20 mL

Rx only

PRINCIPAL DISPLAY PANEL - 20 mg Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0108-05
Contains 10 of NDC 0069-0108-04

10 x 20 mg Single-Use Vials
Rx only

Vecuronium Bromide
for Injection
20 mg*

Lyophilized Powder
For IV Single Use Only

*1 mg/mL when reconstituted to 20 mL

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 20 mg Vial Carton