🇺🇸
United States · US · US:83853-101_49d32782-3faa-4670-99bf-db9b7115f2d0
AQNEURSA
Orange BookUNIISPLATC N07XX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIntraBio Inc
CountryUS (United States)
ATC codeN07XX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11838531010128 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET
Annotations
UNII (FDA Substance ID)
E915HL7K2O
LEVACETYLLEUCINE
Orange Book
N219132
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "E915HL7K2O",
"rxcui": null,
"inchikey": "WXNXCEHXYPACJF-ZETCQYMHSA-N",
"display_name": "LEVACETYLLEUCINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0f248e55-d1bb-13f9-e063-6294a90a05ce": {
"match": "brand_token",
"title": "AQNEURSA (LEVACETYLLEUCINE) GRANULE, FOR SUSPENSION [INTRABIO INC]",
"spl_version": "5",
"published_date": "2025-01-27"
}
},
"productid": "83853-101_49d32782-3faa-4670-99bf-db9b7115f2d0",
"productndc": "83853-101",
"dosage_form": "GRANULE, FOR SUSPENSION",
"orange_book": {
"appl_no": "219132",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1GM/PACKET",
"product_no": "001",
"approval_date": "Sep 24, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVACETYLLEUCINE",
"proprietary_name": "AQNEURSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA219132",
"marketing_category": "NDA",
"nonproprietary_name": "levacetylleucine",
"start_marketing_date": "20240924",
"active_numerator_strength": "1000"
}Related drugs
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