Arsenic Trioxide Injection

SPL v3

SPL

SPL Set ID 25e8295c-b5d9-4322-a093-d907ab1d1d35

Route

INTRAVENOUS

Published

Effective Date 2020-10-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arsenic Cation (3+) (1 mg)

Inactive Ingredients

Sodium Hydroxide Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2018-11-14

Description

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

Medication Information

Description

Section 51945-4

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

Structured Label Content

Section 51945-4 (51945-4)

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

Advanced Ingredient Data

[{"name": "ARSENIC CATION (3+)", "unii": "C96613F5AV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"51945-4": "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:24.735600 · Updated: 2026-03-14T21:49:59.697322