Krystexxa

Product NDC

60809-801

11-digit product format

608090801

Labeler code

60809

Product ID

60809-801_e46925f2-7335-435e-8fe0-f4455fd01c74

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

pegloticase

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Horizon Pharma Inc.

Application

BLA125293

Marketing category

BLA

Marketing start

2010-09-14

Marketing end

0000-00-00

Substance

PEGLOTICASE

Active strength

8 mg/mL

Pharmacologic classes

Urate Oxidase [CS],Uric Acid-specific Enzyme [EPC]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record