Kit for the Preparation of Technetium Tc99m Disofenin

Product NDC

45567-0475

11-digit product format

455670475

Labeler code

45567

Product ID

45567-0475_9466e179-86ab-47e0-b5cf-d73d66624efe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

HEPATOLITE

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Pharmalucence, Inc.

Application

NDA018467

Marketing category

NDA

Marketing start

1982-03-16

Marketing end

0000-00-00

Substance

TECHNETIUM TC-99M DISOFENIN

Active strength

20 mg/10mL

Pharmacologic classes

Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record