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United States · US · US:0074-0501_1f0fe652-c027-4b61-9ba4-78548dd48e89
Vyalev
Orange BookUNIISPLATC N04BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeN04BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100740501017 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
5NT8HCA4OO
FOSCARBIDOPA
Orange Book
N216962
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5NT8HCA4OO",
"rxcui": null,
"inchikey": "PQUZXFMHVSMUNG-JTQLQIEISA-N",
"display_name": "FOSCARBIDOPA",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"28e806e4-951c-40a9-9f0c-d0929caf054c": {
"match": "brand_token",
"title": "VYALEV (FOSCARBIDOPA/FOSLEVODOPA) INJECTION [ABBVIE INC.]",
"spl_version": "6",
"published_date": "2026-04-09"
}
},
"productid": "0074-0501_1f0fe652-c027-4b61-9ba4-78548dd48e89",
"productndc": "0074-0501",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216962",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)",
"product_no": "001",
"approval_date": "Oct 16, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSCARBIDOPA; FOSLEVODOPA",
"proprietary_name": "Vyalev",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA216962",
"marketing_category": "NDA",
"nonproprietary_name": "foscarbidopa/foslevodopa",
"start_marketing_date": "20220412",
"active_numerator_strength": "12; 240"
}Related drugs
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