CISATRACURIUM BESYLATE INJECTION

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

NDC 72785-0008-1

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

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

NDC 72785-0009-1

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

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

NDC 72785-0008-6

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

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

NDC 72785-0009-6

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

CISATRACURIUM BESYLATE
cisatracurium besylate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72785-0008
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N)	CISATRACURIUM	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZENESULFONIC ACID (UNII: 685928Z18A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0008-6	10 in 1 CARTON	02/12/2020
1	NDC:72785-0008-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA212171	02/12/2020

CISATRACURIUM BESYLATE
cisatracurium besylate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72785-0009
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N)	CISATRACURIUM	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZENESULFONIC ACID (UNII: 685928Z18A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72785-0009-6	10 in 1 CARTON	02/12/2020
1	NDC:72785-0009-1	20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA212171	02/12/2020

Labeler - Zydus Lifesciences Limited (873671928)