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United States · US · US:81749-004_48e9b876-94c8-7c9f-e063-6294a90adcef

Tarpeyo

Orange BookUNIISPLATC A07EA06

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

Identification

ManufacturerCalliditas Therapeutics AB
CountryUS (United States)
ATC codeA07EA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8174900401
    120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)

Annotations

UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N215935
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": {
    "938cada4-d6bf-4252-836f-dd40f9eadb4d": {
      "match": "brand_token",
      "title": "TARPEYO (BUDESONIDE) CAPSULE, DELAYED RELEASE [CALLIDITAS THERAPEUTICS AB]",
      "spl_version": "5",
      "published_date": "2026-01-26"
    }
  },
  "productid": "81749-004_48e9b876-94c8-7c9f-e063-6294a90adcef",
  "productndc": "81749-004",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "215935",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 15, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE",
  "proprietary_name": "Tarpeyo",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215935",
  "marketing_category": "NDA",
  "nonproprietary_name": "budesonide",
  "start_marketing_date": "20211215",
  "active_numerator_strength": "4"
}

Related drugs

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