NDC Code(s) : 66794-229-02, 66794-229-41, 66794-228-02, 66794-228-41
Packager : Piramal Critical Care Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RocuroniumRocuronium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66794-229
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROCURONIUM BROMIDE(UNII: I65MW4OFHZ)
(ROCURONIUM - UNII:WRE554RFEZ) 		ROCURONIUM BROMIDE100 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE(UNII: 4550K0SC9B)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66794-229-4110 in 1 CARTON 20/07/2020
1NDC:66794-229-0210 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 ANDA210437 07/20/2020
RocuroniumRocuronium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66794-228
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROCURONIUM BROMIDE(UNII: I65MW4OFHZ)
(ROCURONIUM - UNII:WRE554RFEZ) 		ROCURONIUM BROMIDE50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE(UNII: 4550K0SC9B)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66794-228-4110 in 1 CARTON 20/07/2020
1NDC:66794-228-025 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 ANDA210437 07/20/2020

LABELER - Piramal Critical Care Inc(805600439)

Establishment
Name Address ID/FEI Business Operations
SANOVEL ILAC SANAYI VE TICARET 533148038 manufacture(66794-229, 66794-228)

PRINCIPAL DISPLAY PANEL

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