NDC Code(s) : 0006-5423-02, 0006-5423-12, 0006-5423-05, 0006-5423-15, 0006-5425-05, 0006-5425-15
Packager : Merck Sharp & Dohme LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BRIDIONsugammadex INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5423
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUGAMMADEX SODIUM(UNII: ERJ6X2MXV7)
(SUGAMMADEX - UNII:361LPM2T56) 		SUGAMMADEX100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0006-5423-1210 in 1 CARTON 15/12/2015
1NDC:0006-5423-022 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0006-5423-1510 in 1 CARTON 15/12/2015
2NDC:0006-5423-055 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022225 12/15/2015
BRIDIONsugammadex INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5425
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUGAMMADEX SODIUM(UNII: ERJ6X2MXV7)
(SUGAMMADEX - UNII:361LPM2T56) 		SUGAMMADEX100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0006-5425-1510 in 1 CARTON 06/05/2017
1NDC:0006-5425-055 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022225 12/15/2015

LABELER - Merck Sharp & Dohme LLC(118446553)

PRINCIPAL DISPLAY PANEL

NDC 0006-5423-12

Bridion®
(sugammadex) Injection
200 mg/2 mL (100 mg/mL)

Rx only
10 Single-Dose 2 mL Vials

For Intravenous Use Only

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0006-5425-15

Bridion®
(sugammadex) Injection
500 mg/5 mL (100 mg/mL)

Rx only
10 Single-Dose 5 mL Vials

For Intravenous Use Only

PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton