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United States · US · US:24979-715_533bf14c-835a-d5be-e063-6294a90a7d71

sorafenib

Orange BookUNIISPLATC L01EX02

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeL01EX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2497971504
    60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04)
  • ndc11
    2497971544
    120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44)

Annotations

UNII (FDA Substance ID)
9ZOQ3TZI87
SORAFENIB
RxCUI 495881
Orange Book
A209050
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9ZOQ3TZI87",
    "rxcui": "495881",
    "inchikey": "MLDQJTXFUGDVEO-UHFFFAOYSA-N",
    "display_name": "SORAFENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6": {
      "match": "brand_token",
      "title": "SORAFENIB TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]",
      "spl_version": "7",
      "published_date": "2026-05-21"
    }
  },
  "productid": "24979-715_533bf14c-835a-d5be-e063-6294a90a7d71",
  "productndc": "24979-715",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Nov 9, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SORAFENIB",
  "proprietary_name": "sorafenib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sorafenib",
  "start_marketing_date": "20221201",
  "active_numerator_strength": "200"
}

Related drugs

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