CISATRACURIUM BESYLATE- cisatracurium besylate injection 
Cadila Healthcare Limited

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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

image10

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

image11

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

image12

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

image13
CISATRACURIUM BESYLATE 
cisatracurium besylate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0008
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N) CISATRACURIUM2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZENESULFONIC ACID (UNII: 685928Z18A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72785-0008-610 in 1 CARTON02/12/2020
1NDC:72785-0008-15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21217102/12/2020
CISATRACURIUM BESYLATE 
cisatracurium besylate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0009
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N) CISATRACURIUM10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZENESULFONIC ACID (UNII: 685928Z18A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72785-0009-610 in 1 CARTON02/12/2020
1NDC:72785-0009-120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21217102/12/2020
Labeler - Cadila Healthcare Limited (873671928)

Revised: 10/2020
Document Id: 08af4f3a-a90f-45f8-a710-f97ff9c0b214
Set id: e145a40e-b046-4064-b35e-0da40ff3703e
Version: 2
Effective Time: 20201012
 
Cadila Healthcare Limited