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United States · US · US:71332-002_78828503-b88f-4e3d-9add-8b738c4cf28e

TAVALISSE

Orange BookUNIISPLATC B02BX09

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

Identification

ManufacturerRigel Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeB02BX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133200201
    60 TABLET in 1 BOTTLE (71332-002-01)

Annotations

UNII (FDA Substance ID)
SQ8A3S5101
FOSTAMATINIB
RxCUI 2044896
Orange Book
N209299
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SQ8A3S5101",
    "rxcui": "2044896",
    "inchikey": "GKDRMWXFWHEQQT-UHFFFAOYSA-N",
    "display_name": "FOSTAMATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "21149cc3-049b-43e2-b141-c9499160556c": {
      "match": "brand_token",
      "title": "TAVALISSE (FOSTAMATINIB) TABLET [RIGEL PHARMACEUTICALS, INC.]",
      "spl_version": "11",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71332-002_78828503-b88f-4e3d-9add-8b738c4cf28e",
  "productndc": "71332-002",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209299",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Apr 17, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Apr 17, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSTAMATINIB",
  "proprietary_name": "TAVALISSE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209299",
  "marketing_category": "NDA",
  "nonproprietary_name": "FOSTAMATINIB",
  "start_marketing_date": "20180509",
  "active_numerator_strength": "150"
}

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