Arsenic Trioxide Injection

SPL v3

SPL

SPL Set ID 2ad7bb19-6152-4158-a179-2388e86a981f

Route

INTRAVENOUS

Published

Effective Date 2019-09-04

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arsenic Cation (3+) (2 mg)

Inactive Ingredients

Sodium Hydroxide Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2019-09-03

Description

PRINCIPAL DISPLAY PANEL - Vial Label NDC 49315-007-01 Arsenic Trioxide Injection 12 mg/6 mL (2 mg/mL) NEW CONCENTRATION For Intravenous Use Only Cytotoxic Agent 6 mL Single-Dose Vial Rx only Zydus Pharmaceuticals PRINCIPAL DISPLAY PANEL - Carton Label NDC 49315-007-10 Arsenic Trioxide Injection 12 mg/6 mL (2 mg/mL) NEW CONCENTRATION For Intravenous Use Only 10 X 6 mL Single-Dose Vials Rx only Zydus Pharmaceuticals

Medication Information

Description

Section 51945-4

PRINCIPAL DISPLAY PANEL - Vial Label

NDC 49315-007-01

Arsenic Trioxide Injection

12 mg/6 mL

(2 mg/mL)

NEW CONCENTRATION

For Intravenous Use Only

Cytotoxic Agent

6 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - Carton Label

NDC 49315-007-10

Arsenic Trioxide Injection

12 mg/6 mL

(2 mg/mL)

NEW CONCENTRATION

For Intravenous Use Only

10 X 6 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

Structured Label Content

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL - Vial Label

NDC 49315-007-01

Arsenic Trioxide Injection

12 mg/6 mL

(2 mg/mL)

NEW CONCENTRATION

For Intravenous Use Only

Cytotoxic Agent

6 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - Carton Label

NDC 49315-007-10

Arsenic Trioxide Injection

12 mg/6 mL

(2 mg/mL)

NEW CONCENTRATION

For Intravenous Use Only

10 X 6 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

Advanced Ingredient Data

[{"name": "ARSENIC CATION (3+)", "unii": "C96613F5AV", "classCode": "ACTIB", "strengthNumerator": "2", "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 49315-007-01 Arsenic Trioxide Injection 12 mg/6 mL (2 mg/mL) NEW CONCENTRATION For Intravenous Use Only Cytotoxic Agent 6 mL Single-Dose Vial Rx only Zydus Pharmaceuticals PRINCIPAL DISPLAY PANEL - Carton Label NDC 49315-007-10 Arsenic Trioxide Injection 12 mg/6 mL (2 mg/mL) NEW CONCENTRATION For Intravenous Use Only 10 X 6 mL Single-Dose Vials Rx only Zydus Pharmaceuticals"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:24.736983 · Updated: 2026-03-14T21:49:59.697322