NDC Code(s) : 70710-1533-1, 70710-1533-6
Packager : Zydus Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

cisatracurium besylate cisatracurium besylate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1533
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CISATRACURIUM BESYLATE(UNII: 80YS8O1MBS)
(CISATRACURIUM - UNII:QX62KLI41N) 		CISATRACURIUM2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZENESULFONIC ACID(UNII: 685928Z18A)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70710-1533-610 in 1 CARTON 11/05/2020
1NDC:70710-1533-110 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 ANDA213527 11/05/2020

LABELER - Zydus Pharmaceuticals USA Inc.(156861945)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Container Label (20 mg/10 mL)

NDC 70710-1533-1

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 mL Multiple-Dose Vial

Rx only

Zydus Pharmaceuticals

image10

Principal Display Panel – Carton Label (20 mg/10 mL)

NDC 70710-1533-1

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 mL Multiple-Dose Vial

Rx only

Zydus Pharmaceuticals

image10

Principal Display Panel – Carton Label (20 mg/10 mL)

NDC 70710-1533-6

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 X 10 mL Multiple-Dose Vials

Rx only

Zydus Pharmaceuticals

image10