NDC 83107-030-01 - Ethyol

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: 83107-030
Requested NDC: 83107-030-01
Package NDCs from labels: 83107-030-01, 83107-030-02
Manufacturer: Legacy Pharma USA Inc.
Effective date: 2026-03-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ethyol - Legacy Pharma USA Inc.	Legacy Pharma USA Inc.	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83107-030-01	Ethyol	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		2
83107-030-02	Ethyol	3 in 1 CARTON	INJECTION	3		2

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethyol	AMIFOSTINE	Legacy Pharma USA Inc.	a17563f2-d231-4385-bc94-0217be78b89d	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: NDA020221 ndc (package): 83107-030-01 ndc (package): 83107-030-02 ndc (product): 83107-030 ndc11 (package): 83107003001 rxcui: 308096 rxcui: 1803018 spl id: 4c20479c-d75a-a0c7-e063-6394a90a9e59 spl set id: a17563f2-d231-4385-bc94-0217be78b89d unii: M487QF2F4V

Reported adverse events (FAERS/openFDA)#

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