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United States · US · US:63090-663_d88ad1a8-3656-4de5-811a-bcebb0c76567
Daybue Stix
Orange BookUNIISPLATC N07XX24
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcadia Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN07XX24
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11630906636060 PACKET in 1 CARTON (63090-663-60) / 1 FOR SOLUTION in 1 PACKET (63090-663-01)
Annotations
UNII (FDA Substance ID)
Z2ME8F52QL
TROFINETIDE
Orange Book
N219884
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Z2ME8F52QL",
"rxcui": null,
"inchikey": "BUSXWGRAOZQTEY-SDBXPKJASA-N",
"display_name": "TROFINETIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"67e6f2d9-21f6-466f-9def-826c6a4b8257": {
"match": "brand_token",
"title": "DAYBUE (TROFINETIDE) SOLUTION DAYBUE STIX (TROFINETIDE) FOR SOLUTION [ACADIA PHARMACEUTICALS INC.]",
"spl_version": "10",
"published_date": "2026-04-13"
}
},
"productid": "63090-663_d88ad1a8-3656-4de5-811a-bcebb0c76567",
"productndc": "63090-663",
"dosage_form": "FOR SOLUTION",
"orange_book": {
"appl_no": "219884",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5000MG/PACKET",
"product_no": "001",
"approval_date": "Dec 11, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "6000MG/PACKET",
"product_no": "002",
"approval_date": "Dec 11, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "8000MG/PACKET",
"product_no": "003",
"approval_date": "Dec 11, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TROFINETIDE",
"proprietary_name": "Daybue Stix",
"active_ingred_unit": "mg/1",
"application_number": "NDA219884",
"marketing_category": "NDA",
"nonproprietary_name": "trofinetide",
"start_marketing_date": "20251211",
"active_numerator_strength": "5000"
}Related drugs
Other records sharing ATC code N07XX24.
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