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United States · US · US:71332-005_6df73356-e3c1-498d-af08-c34b5d257bdb

REZLIDHIA

Orange BookUNIISPLATC L01XM03

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

Identification

ManufacturerRigel Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XM03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133200501
    30 CAPSULE in 1 BOTTLE (71332-005-01)

Annotations

UNII (FDA Substance ID)
0T4IMT8S5Z
OLUTASIDENIB
RxCUI 2623641
Orange Book
N215814
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0T4IMT8S5Z",
    "rxcui": "2623641",
    "inchikey": "NEQYWYXGTJDAKR-JTQLQIEISA-N",
    "display_name": "OLUTASIDENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4a0c7c8b-b95f-455d-9600-b7351e4397fe": {
      "match": "brand_token",
      "title": "REZLIDHIA (OLUTASIDENIB) CAPSULE [RIGEL PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71332-005_6df73356-e3c1-498d-af08-c34b5d257bdb",
  "productndc": "71332-005",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215814",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Dec 1, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLUTASIDENIB",
  "proprietary_name": "REZLIDHIA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215814",
  "marketing_category": "NDA",
  "nonproprietary_name": "olutasidenib",
  "start_marketing_date": "20221201",
  "active_numerator_strength": "150"
}

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