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United States · US · US:64764-105_6b8f012a-d7af-4200-a5b8-5a56f6962ccd

Eohilia

Orange BookUNIISPLATC A07EA06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTAKEDA PHARMACEUTICALS AMERICA, INC.
CountryUS (United States)
ATC codeA07EA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6476410500
    10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01)
  • ndc11
    6476410560
    60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10)

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N213976
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q3OKS62Q6X",
    "rxcui": "19831",
    "inchikey": "VOVIALXJUBGFJZ-KWVAZRHASA-N",
    "display_name": "BUDESONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "56f2023a-69b2-4470-b4ad-af7ec1be527a": {
      "match": "brand_token",
      "title": "EOHILIA (BUDESONIDE) SUSPENSION [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "6",
      "published_date": "2025-02-06"
    }
  },
  "productid": "64764-105_6b8f012a-d7af-4200-a5b8-5a56f6962ccd",
  "productndc": "64764-105",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "213976",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG/10ML",
        "product_no": "001",
        "approval_date": "Feb 9, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "Eohilia",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA213976",
  "marketing_category": "NDA",
  "nonproprietary_name": "Budesonide",
  "start_marketing_date": "20240209",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07EA06.

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