NDC 68083-462-01 - Arsenic Trioxide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68083-462
Requested NDC: 68083-462-01
Package NDCs from labels: 68083-462-01, 68083-462-10
Manufacturer: Gland Pharma Limited
Effective date: 2024-09-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Arsenic Trioxide - Gland Pharma Limited	Gland Pharma Limited	2024-09-12	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-462-01	Arsenic Trioxide	6 mL in 1 VIAL, SINGLE-DOSE	INJECTION	6		8
68083-462-10	Arsenic Trioxide	10 in 1 CARTON	INJECTION	10		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-462	ARSENIC TRIOXIDE INJECTION [GLAND PHARMA LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20240913_2cb52683-1e74-4831-a771-55a78536cfe5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 47 of 47 · 922 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cerebroforce	CAPSICUM ANNUUM, GINKGO BILOBA, GELSEMIUM SEMPERVIRENS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ARSENICUM ALBUM	BioActive Nutritional, Inc	f998ed3f-56a5-4497-be5b-9a819fe8be69	2016-07-13	Warnings	Exact identifier unii: S7V92P67HO
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.