FDA.reportPublic FDA data

CRYSVITA

Product NDC
42747-304
11-digit product format
427470304
Labeler code
42747
Product ID
42747-304_59579885-f5a8-41ba-bfc7-5e3adcc1cbce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Burosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Kyowa Kirin, Inc.
Application
BLA761068
Marketing category
BLA
Marketing start
2018-04-18
Substance
BUROSUMAB
Active strength
30 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CRYSVITA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUROSUMAB30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG9WJT6RD29
Rxcui2043859, 2043864, 2043868, 2043870, 2043876, 2043878

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5da468b5-2d28-44fa-af0c-327e5587cf7fProduct name120180619
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42747-304-01CRYSVITA1 mL in 1 VIAL, SINGLE-USEINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42747-304-01ML - Milliliter42747-30436915c30-9392-4ffc-914b-1ea796c6525c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42747-304CRYSVITA (BUROSUMAB) INJECTION [KYOWA KIRIN, INC.]4Current NDC, 1 package rows20241106_102f96a0-6e3a-4fc1-b204-34d604683af6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2043859burosumab-twza 10 MG in 1 ML InjectionPSN102f96a0-6e3a-4fc1-b204-34d604683af65
2043868burosumab-twza 20 MG in 1 ML InjectionPSN102f96a0-6e3a-4fc1-b204-34d604683af65
2043876burosumab-twza 30 MG in 1 ML InjectionPSN102f96a0-6e3a-4fc1-b204-34d604683af65
2043864CRYSViTA 10 MG in 1 ML InjectionPSN102f96a0-6e3a-4fc1-b204-34d604683af65
2043870CRYSViTA 20 MG in 1 ML InjectionPSN102f96a0-6e3a-4fc1-b204-34d604683af65
2043878CRYSViTA 30 MG in 1 ML InjectionPSN102f96a0-6e3a-4fc1-b204-34d604683af65
20438641 ML burosumab-twza 10 MG/ML Injection [Crysvita]SBD102f96a0-6e3a-4fc1-b204-34d604683af65
20438701 ML burosumab-twza 20 MG/ML Injection [Crysvita]SBD102f96a0-6e3a-4fc1-b204-34d604683af65
20438781 ML burosumab-twza 30 MG/ML Injection [Crysvita]SBD102f96a0-6e3a-4fc1-b204-34d604683af65
20438591 ML burosumab-twza 10 MG/ML InjectionSCD102f96a0-6e3a-4fc1-b204-34d604683af65
20438681 ML burosumab-twza 20 MG/ML InjectionSCD102f96a0-6e3a-4fc1-b204-34d604683af65
20438761 ML burosumab-twza 30 MG/ML InjectionSCD102f96a0-6e3a-4fc1-b204-34d604683af65
2043859burosumab-twza 10 MG per 1 ML InjectionSY102f96a0-6e3a-4fc1-b204-34d604683af65
2043868burosumab-twza 20 MG per 1 ML InjectionSY102f96a0-6e3a-4fc1-b204-34d604683af65
2043876burosumab-twza 30 MG per 1 ML InjectionSY102f96a0-6e3a-4fc1-b204-34d604683af65
2043864Crysvita 10 MG per 1 ML InjectionSY102f96a0-6e3a-4fc1-b204-34d604683af65
2043870Crysvita 20 MG per 1 ML InjectionSY102f96a0-6e3a-4fc1-b204-34d604683af65
2043878Crysvita 30 MG per 1 ML InjectionSY102f96a0-6e3a-4fc1-b204-34d604683af65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42747-304-01427470304011 mL in 1 VIAL, SINGLE-USE (42747-304-01) 1 ml2023-09-01NoNoHistorical