Label: CISATRACURIUM BESYLATE injection
- NDC Code(s): 72785-0011-1, 72785-0011-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 72758-0011-1
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
NDC 72758-0011-1
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
NDC 72758-0011-6
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 Vial
Rx only
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INGREDIENTS AND APPEARANCE
CISATRACURIUM BESYLATE
cisatracurium besylate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0011 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N) CISATRACURIUM 2 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 1 NDC:72785-0011-6 10 in 1 CARTON 11/05/2020 1 NDC:72785-0011-1 10 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 Lifesciences Limited (873671928) Registrant - Zydus Lifesciences Limited (873671928) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(72785-0011) , ANALYSIS(72785-0011)