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United States · US · US:51990-201_533bf507-3ac8-7c25-e063-6294a90a7ff2

sorafenib

Orange BookUNIISPLATC L01EX02

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

Identification

ManufacturerYabao Pharmaceutical Co., Ltd. Beijing
CountryUS (United States)
ATC codeL01EX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5199020106
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06)
  • ndc11
    5199020112
    120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12)

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": "51990-201_533bf507-3ac8-7c25-e063-6294a90a7ff2",
  "productndc": "51990-201",
  "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

Other records sharing ATC code L01EX02.

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