NDC Code(s) : 70710-1532-1, 70710-1532-6, 70710-1534-1, 70710-1534-6
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:70710-1532
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)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70710-1532-610 in 1 CARTON 02/12/2020
1NDC:70710-1532-15 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 ANDA212171 02/12/2020
cisatracurium besylate cisatracurium besylate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1534
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CISATRACURIUM BESYLATE(UNII: 80YS8O1MBS)
(CISATRACURIUM - UNII:QX62KLI41N) 		CISATRACURIUM10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZENESULFONIC ACID(UNII: 685928Z18A)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70710-1534-610 in 1 CARTON 02/12/2020
1NDC:70710-1534-120 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 ANDA212171 02/12/2020

LABELER - Zydus Pharmaceuticals USA Inc.(156861945)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Container Label (10 mg/5 mL)

NDC 70710-1532-1

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

5 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

image10

Principal Display Panel – Container Label (200 mg/20 mL)

NDC 70710-1534-1

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

20 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

image10

Principal Display Panel – Carton Label (10 mg/5 mL)

NDC 70710-1532-6

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

10 x 5 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

image10

Principal Display Panel – Carton Label (200 mg/20 mL)

NDC 70710-1534-6

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

10 x 20 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

image10