CRYSVITA

Product NDC
69794-203
11-digit product format
697940203
Labeler code
69794
Product ID
69794-203_81078e03-384d-40f9-a5e9-9b8b49163a32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Burosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Ultragenyx Pharmaceutical Inc.
Application
BLA761068
Marketing category
BLA
Marketing start
2018-04-18
Marketing end
0000-00-00
Substance
BUROSUMAB
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69794-203-01ML - Milliliter69794-203ea02f5d7-7f58-45b7-8f13-5aef7c8961ea12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69794-203-01697940203011 mL in 1 VIAL, SINGLE-USE (69794-203-01) 1 ml2018-04-180000-00-00NoNoCurrent