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United States · US · US:68135-082_6100caa6-4951-4773-b80c-6be0c04efd24
VOXZOGO 0.4mg
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBioMarin Pharmaceutical Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168135082361 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12)
Annotations
Orange Book
N214938
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"228e8560-04a4-4bb1-a81f-29531a9e4d27": {
"match": "brand_token",
"title": "VOXZOGO 0.4MG (VOSORITIDE) KIT VOXZOGO 0.56MG (VOSORITIDE) KIT VOXZOGO 1.2MG (VOSORITIDE) KIT [BIOMARIN PHARMACEUTICAL INC.]",
"spl_version": "16",
"published_date": "2025-11-26"
}
},
"productid": "68135-082_6100caa6-4951-4773-b80c-6be0c04efd24",
"productndc": "68135-082",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "214938",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.4MG/VIAL",
"product_no": "001",
"approval_date": "Nov 19, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.56MG/VIAL",
"product_no": "002",
"approval_date": "Nov 19, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.2MG/VIAL",
"product_no": "003",
"approval_date": "Nov 19, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "VOXZOGO 0.4mg",
"active_ingred_unit": null,
"application_number": "NDA214938",
"marketing_category": "NDA",
"nonproprietary_name": "vosoritide",
"start_marketing_date": "20211119",
"active_numerator_strength": null
}Access this data programmatically
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