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United States · US · US:43376-322_42264a61-0fc3-3a99-e063-6294a90a9595
Fintepla
Orange BookUNIISPLATC N03AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUCB, Inc.
CountryUS (United States)
ATC codeN03AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1143376322301 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC
- ndc1143376322361 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
2DS058H2CF
FENFLURAMINE
RxCUI 4328
Orange Book
N212102
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2DS058H2CF",
"rxcui": "4328",
"inchikey": "DBGIVFWFUFKIQN-UHFFFAOYSA-N",
"display_name": "FENFLURAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e88f360e-33ad-4cd6-b2de-5ef885857c5d": {
"match": "brand_token",
"title": "FINTEPLA (FENFLURAMINE) SOLUTION [UCB, INC.]",
"spl_version": "16",
"published_date": "2025-11-17"
}
},
"productid": "43376-322_42264a61-0fc3-3a99-e063-6294a90a9595",
"productndc": "43376-322",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212102",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2.2MG BASE/ML",
"product_no": "001",
"approval_date": "Jun 25, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FENFLURAMINE",
"proprietary_name": "Fintepla",
"active_ingred_unit": "mg/mL",
"application_number": "NDA212102",
"marketing_category": "NDA",
"nonproprietary_name": "fenfluramine",
"start_marketing_date": "20200715",
"active_numerator_strength": "2.2"
}Related drugs
Other records sharing ATC code N03AX26.
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