crysvita

Generic: burosumab

Labeler: kyowa kirin, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name crysvita
Generic Name burosumab
Labeler kyowa kirin, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

burosumab 10 mg/mL

Manufacturer
Kyowa Kirin, Inc.

Identifiers & Regulatory

Product NDC 42747-102
Product ID 42747-102_59579885-f5a8-41ba-bfc7-5e3adcc1cbce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761068
Listing Expiration 2026-12-31
Marketing Start 2018-04-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42747102
Hyphenated Format 42747-102

Supplemental Identifiers

RxCUI
2043859 2043864 2043868 2043870 2043876 2043878
UNII
G9WJT6RD29

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name crysvita (source: ndc)
Generic Name burosumab (source: ndc)
Application Number BLA761068 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-USE (42747-102-01)
source: ndc

Packages (1)

42747-102-01 1 mL in 1 VIAL, SINGLE-USE (42747-102-01)

Ingredients (1)

burosumab (10 mg/mL)

Linked Drug Pages (1)

CRYSVITA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "59579885-f5a8-41ba-bfc7-5e3adcc1cbce", "openfda": {"unii": ["G9WJT6RD29"], "rxcui": ["2043859", "2043864", "2043868", "2043870", "2043876", "2043878"], "spl_set_id": ["102f96a0-6e3a-4fc1-b204-34d604683af6"], "manufacturer_name": ["Kyowa Kirin, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-USE (42747-102-01)", "package_ndc": "42747-102-01", "marketing_start_date": "20230901"}], "brand_name": "CRYSVITA", "product_id": "42747-102_59579885-f5a8-41ba-bfc7-5e3adcc1cbce", "dosage_form": "INJECTION", "product_ndc": "42747-102", "generic_name": "Burosumab", "labeler_name": "Kyowa Kirin, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CRYSVITA", "active_ingredients": [{"name": "BUROSUMAB", "strength": "10 mg/mL"}], "application_number": "BLA761068", "marketing_category": "BLA", "marketing_start_date": "20180418", "listing_expiration_date": "20261231"}