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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

  • ndc11
    8385310101
    28 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

Other records sharing ATC code N07XX.

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