CRYSVITA

Product NDC: 69794-304
11-digit product format: 697940304
Labeler code: 69794
Product ID: 69794-304_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: 30 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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69794-304-01	ML - Milliliter	69794-304	ff485145-3f13-4f95-9ca8-9cdca807b5fe	1	2018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69794-304-01	69794030401	1 mL in 1 VIAL, SINGLE-USE (69794-304-01)	1 ml	2018-04-18	0000-00-00	No	No	Current