CRYSVITA

Product NDC: 42747-102
11-digit product format: 427470102
Labeler code: 42747
Product ID: 42747-102_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: 10 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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUROSUMAB	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G9WJT6RD29	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2043859	Internal RxNorm lookup
2043864	Internal RxNorm lookup
2043868	Internal RxNorm lookup
2043870	Internal RxNorm lookup
2043876	Internal RxNorm lookup
2043878	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
102f96a0-6e3a-4fc1-b204-34d604683af6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5da468b5-2d28-44fa-af0c-327e5587cf7f	Product name	1	20180619
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42747-102-01	CRYSVITA	1 mL in 1 VIAL, SINGLE-USE	INJECTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42747-102-01	ML - Milliliter	42747-102	fc47c74a-c8c9-41a0-b24a-8f8538a5be9c	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42747-102	CRYSVITA (BUROSUMAB) INJECTION [KYOWA KIRIN, INC.]	4	Current NDC, 1 package rows	20241106_102f96a0-6e3a-4fc1-b204-34d604683af6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CRYSVITA	BUROSUMAB	Kyowa Kirin, Inc.	102f96a0-6e3a-4fc1-b204-34d604683af6	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: BLA761068 ndc (product): 42747-102

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761068	Crysvita	burosumab-twza	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G9WJT6RD29	BUROSUMAB	1610833-03-8	BUROSUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2043859	burosumab-twza 10 MG in 1 ML Injection	PSN	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043868	burosumab-twza 20 MG in 1 ML Injection	PSN	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043876	burosumab-twza 30 MG in 1 ML Injection	PSN	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043864	CRYSViTA 10 MG in 1 ML Injection	PSN	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043870	CRYSViTA 20 MG in 1 ML Injection	PSN	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043878	CRYSViTA 30 MG in 1 ML Injection	PSN	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043864	1 ML burosumab-twza 10 MG/ML Injection [Crysvita]	SBD	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043870	1 ML burosumab-twza 20 MG/ML Injection [Crysvita]	SBD	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043878	1 ML burosumab-twza 30 MG/ML Injection [Crysvita]	SBD	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043859	1 ML burosumab-twza 10 MG/ML Injection	SCD	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043868	1 ML burosumab-twza 20 MG/ML Injection	SCD	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043876	1 ML burosumab-twza 30 MG/ML Injection	SCD	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043859	burosumab-twza 10 MG per 1 ML Injection	SY	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043868	burosumab-twza 20 MG per 1 ML Injection	SY	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043876	burosumab-twza 30 MG per 1 ML Injection	SY	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043864	Crysvita 10 MG per 1 ML Injection	SY	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043870	Crysvita 20 MG per 1 ML Injection	SY	102f96a0-6e3a-4fc1-b204-34d604683af6	5
2043878	Crysvita 30 MG per 1 ML Injection	SY	102f96a0-6e3a-4fc1-b204-34d604683af6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42747-102-01	42747010201	1 mL in 1 VIAL, SINGLE-USE (42747-102-01)	1 ml	2023-09-01	No	No	Current