Label: ARSENIC TRIOXIDE injection, solution
- NDC Code(s): 49315-005-01, 49315-005-10
- 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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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - Vial Label
NDC 49315-005-01
Arsenic Trioxide Injection
10 mg/10 mL
(1 mg/mL)
For Intravenous Use Only
Cytotoxic Agent
10 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL - Carton Label
NDC 49315-005-10
Arsenic Trioxide Injection
10 mg/10 mL
(1 mg/mL)
For Intravenous Use Only
10 X 10 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
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INGREDIENTS AND APPEARANCE
ARSENIC TRIOXIDE
arsenic trioxide injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49315-005 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49315-005-10 10 in 1 CARTON 11/14/2018 1 NDC:49315-005-01 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 ANDA206228 11/14/2018 Labeler - Zydus Lifesciences Limited (650348852) Registrant - Zydus Lifesciences Limited (650348852) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650348852 ANALYSIS(49315-005) , MANUFACTURE(49315-005)