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United States · US · US:63090-660_d88ad1a8-3656-4de5-811a-bcebb0c76567
Daybue
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
- ndc1163090660011 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
Z2ME8F52QL
TROFINETIDE
Orange Book
N217026
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": "63090-660_d88ad1a8-3656-4de5-811a-bcebb0c76567",
"productndc": "63090-660",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "217026",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG/ML",
"product_no": "001",
"approval_date": "Mar 10, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TROFINETIDE",
"proprietary_name": "Daybue",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217026",
"marketing_category": "NDA",
"nonproprietary_name": "trofinetide",
"start_marketing_date": "20230310",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N07XX24.
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