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United States · US · US:43598-458_b89d7cf3-c673-51c1-7ceb-9ce1cc1ad925

sorafenib

Orange BookUNIISPLATC L01EX02

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

Identification

ManufacturerDr.Reddys Laboratories Inc
CountryUS (United States)
ATC codeL01EX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359845804
    120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04)
  • ndc11
    4359845836
    360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36)

Annotations

UNII (FDA Substance ID)
5T62Q3B36J
SORAFENIB TOSYLATE
RxCUI 597744
Orange Book
A216073
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5T62Q3B36J",
    "rxcui": "597744",
    "inchikey": "IVDHYUQIDRJSTI-UHFFFAOYSA-N",
    "display_name": "SORAFENIB TOSYLATE",
    "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": "43598-458_b89d7cf3-c673-51c1-7ceb-9ce1cc1ad925",
  "productndc": "43598-458",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216073",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Jun 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SORAFENIB TOSYLATE",
  "proprietary_name": "sorafenib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216073",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sorafenib",
  "start_marketing_date": "20220608",
  "active_numerator_strength": "200"
}

Related drugs

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