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United States · US · US:0078-0698_8903ad5f-436d-46ae-9f34-8415cbb8d993

RYDAPT

Orange BookUNIISPLATC L01EX10

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EX10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0078069819
    4 CARTON in 1 CARTON (0078-0698-19) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)
  • ndc11
    0078069899
    2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)

Annotations

UNII (FDA Substance ID)
ID912S5VON
MIDOSTAURIN
RxCUI 1919083
Orange Book
N207997
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ID912S5VON",
    "rxcui": "1919083",
    "inchikey": "BMGQWWVMWDBQGC-IIFHNQTCSA-N",
    "display_name": "MIDOSTAURIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "11fa3fc9-6776-49a6-b1c1-653f627c3e58": {
      "match": "brand_token",
      "title": "RYDAPT CAPSULE, LIQUID FILLED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "14",
      "published_date": "2025-06-20"
    }
  },
  "productid": "0078-0698_8903ad5f-436d-46ae-9f34-8415cbb8d993",
  "productndc": "0078-0698",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "207997",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIDOSTAURIN",
  "proprietary_name": "RYDAPT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207997",
  "marketing_category": "NDA",
  "nonproprietary_name": "RYDAPT",
  "start_marketing_date": "20170428",
  "active_numerator_strength": "25"
}

Related drugs

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