OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Humulin R U-500

insulin human

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Humulin R U-500
Proper name
insulin human
Licence type
351(a)
BLA number
018780
Applicant
Eli Lilly and Company
Center
CDER
Presentations
2
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
1,500UNITS/3ML (500UNITS/ML) Injection Subcutaneous Autoinjector Rx December 29, 2015
10,000UNITS/20ML (500UNITS/ML) Injection Subcutaneous Multi-Dose Vial Rx March 31, 1994

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity