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NDC 49315-0005-10 Arsenic trioxide 1 mg/mL Details

Arsenic trioxide 1 mg/mL

Arsenic trioxide is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is ARSENIC TRIOXIDE.

MedlinePlus Drug Summary

Arsenic trioxide is used in combination with tretinoin to treat acute promyelocytic leukemia (APL; a type of cancer in which there are too many immature blood cells in the blood and bone marrow) in certain people as a first treatment. It is also used to treat APL in certain people who have not been helped by other types of chemotherapy or whose condition has improved but then worsened following treatment with a retinoid and other types of chemotherapy treatment(s). Arsenic trioxide is in a class of medications called anti-neoplastics. It works by slowing or stopping the growth of cancer cells.

Related Packages: 49315-0005-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Arsenic Trioxide Injection

Product Information

NDC	49315-0005
Product ID	49315-005_a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Arsenic trioxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arsenic trioxide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAVENOUS
Active Ingredient Strength	1
Active Ingredient Units	mg/mL
Substance Name	ARSENIC TRIOXIDE
Labeler Name	Zydus Lifesciences Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206228
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49315-0005-10 (49315000510)

Pricing Information	N/A
NDC Package Code	49315-005-10
Billing NDC	49315000510
Package	10 VIAL in 1 CARTON (49315-005-10) / 10 mL in 1 VIAL (49315-005-01)
Marketing Start Date	2018-11-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 25e8295c-b5d9-4322-a093-d907ab1d1d35 Details

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ARSENIC TRIOXIDE

arsenic trioxide injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49315-005
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206228	11/14/2018

Labeler - Zydus Lifesciences Limited (650348852)

Registrant - Zydus Lifesciences Limited (650348852)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		650348852	ANALYSIS(49315-005) , MANUFACTURE(49315-005)

Revised: 11/2022

Document Id: a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5

Set id: 25e8295c-b5d9-4322-a093-d907ab1d1d35

Version: 3

Effective Time: 20221105