NDC Code(s) : 0703-2812-01, 0703-2812-04, 0703-2823-01, 0703-2823-04, 0703-2804-01, 0703-2804-03
Packager : Teva Parenteral Medicines, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pancuronium BromidePancuronium Bromide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-2812
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCURONIUM BROMIDE(UNII: U9LY9Y75X2)
(PANCURONIUM - UNII:J76UF062FS) 		PANCURONIUM BROMIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0703-2812-0425 in 1 TRAY
1NDC:0703-2812-012 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072760 08/01/1990
Pancuronium BromidePancuronium Bromide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-2823
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCURONIUM BROMIDE(UNII: U9LY9Y75X2)
(PANCURONIUM - UNII:J76UF062FS) 		PANCURONIUM BROMIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0703-2823-0425 in 1 TRAY
1NDC:0703-2823-015 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072760 08/01/1990
Pancuronium BromidePancuronium Bromide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-2804
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANCURONIUM BROMIDE(UNII: U9LY9Y75X2)
(PANCURONIUM - UNII:J76UF062FS) 		PANCURONIUM BROMIDE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0703-2804-0310 in 1 TRAY
1NDC:0703-2804-0110 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072759 08/01/1990

PRINCIPAL DISPLAY PANEL

Pancuronium Bromide Injection 4 mg/2 mL Vails, 25 Vial Tray Label

PRINCIPAL DISPLAY PANEL

Pancuronium Bromide Injection 10 mg/5 mL Multiple Dose Vials, 25 Vial Tray Label

PRINCIPAL DISPLAY PANEL

Pancuronium Bromide Injection 10 mg/10 mL Multiple Dose Vials, 10 Vial Tray Label