NDC Code(s) : 72572-067-01, 72572-067-10
Packager : Civica, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

cisatracurium besylatecisatracurium besylate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-067
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:72572-067-1010 in 1 CARTON 21/12/2022
1NDC:72572-067-011 in 1 BOX
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 ANDA200154 12/21/2022

LABELER - Civica, Inc.(081373942)

PRINCIPAL DISPLAY PANEL

  •  NDC 72572-067-10 Rx Only

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

  •  WARNING: Paralyzing Agent. For ICU use only Sterile, Nonpyrogenic

For Intravenous Injection

Discard Unused Portion

10 x 20 mL Single-dose vials

CIVICA

carton