Label: CISATRACURIUM BESYLATE injection
- NDC Code(s): 72785-0008-1, 72785-0008-6, 72785-0009-1, 72785-0009-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
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
-
INGREDIENTS AND APPEARANCE
CISATRACURIUM BESYLATE
cisatracurium besylate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0008 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) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212171 02/12/2020 CISATRACURIUM BESYLATE
cisatracurium besylate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0009 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N) CISATRACURIUM 10 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 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212171 02/12/2020 Labeler - Zydus Lifesciences Limited (873671928)