Ultragenyx Pharmaceutical Inc.
Novato, CA 94949
U.S. License No. 2040
Distributed by:
Ultragenyx Pharmaceutical Inc.
Novato, CA 94949 USA
PRINCIPAL DISPLAY PANEL
NDC 69794-102-01
CRYSVITA
(burosumab-twza)
Injection
10 mg/mL
For Subcutaneous Use Only
Single-Dose Vial
Discard Unused Portion
1 Vial
Rx Only
PRINCIPAL DISPLAY PANEL
NDC 69794-102-01
CRYSVITA
(burosumab-twza)
Injection
10 mg/mL
For Subcutaneous Use Only
Single-Dose Vial
Discard Unused Portion
1 Vial
Rx Only
PRINCIPAL DISPLAY PANEL
NDC 69794-203-01
CRYSVITA
(burosumab-twza)
Injection
20 mg/mL
For Subcutaneous Use Only
Single-Dose Vial
Discard Unused Portion
1 Vial
Rx Only
PRINCIPAL DISPLAY PANEL
NDC 69794-203-01
CRYSVITA
(burosumab-twza)
Injection
20 mg/mL
For Subcutaneous Use Only
Single-Dose Vial
Discard Unused Portion
1 Vial
Rx Only
PRINCIPAL DISPLAY PANEL
NDC 69794-304-01
CRYSVITA
(burosumab-twza)
Injection
30 mg/mL
For Subcutaneous Use Only
Single-Dose Vial
Discard Unused Portion
1 Vial
Rx Only
PRINCIPAL DISPLAY PANEL
NDC 69794-304-01
CRYSVITA
(burosumab-twza)
Injection
30 mg/mL
For Subcutaneous Use Only
Single-Dose Vial
Discard Unused Portion
1 Vial
Rx Only
INGREDIENTS AND APPEARANCE
CRYSVITA
burosumab injection
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69794-102
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
BUROSUMAB (UNII: G9WJT6RD29) (BUROSUMAB - UNII:G9WJT6RD29) BUROSUMAB 10 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R) 45.91 mg in 1 mL
HISTIDINE (UNII: 4QD397987E) 1.55 mg in 1 mL
METHIONINE (UNII: AE28F7PNPL) 1.49 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.50 mg in 1 mL
WATER (UNII: 059QF0KO0R)
OTHER INGREDIENTS
Ingredient Kind Ingredient Name Quantity
May contain HYDROCHLORIC ACID (UNII: QTT17582CB)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69794-102-01 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 04/18/2018
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761068 04/18/2018
CRYSVITA
burosumab injection
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69794-304
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
BUROSUMAB (UNII: G9WJT6RD29) (BUROSUMAB - UNII:G9WJT6RD29) BUROSUMAB 30 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R) 45.91 mg in 1 mL
HISTIDINE (UNII: 4QD397987E) 1.55 mg in 1 mL
METHIONINE (UNII: AE28F7PNPL) 1.49 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.50 mg in 1 mL
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