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United States · US · US:47335-303_001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3

Odomzo

Orange BookUNIISPLATC L01XJ02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL01XJ02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4733530315
    30 CAPSULE in 1 BOTTLE (47335-303-15)
  • ndc11
    4733530383
    30 CAPSULE in 1 BOTTLE (47335-303-83)

Annotations

UNII (FDA Substance ID)
W421AI34UW
SONIDEGIB PHOSPHATE
RxCUI 1659192
Orange Book
N205266
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W421AI34UW",
    "rxcui": "1659192",
    "inchikey": "RWIVSVMMGFFZIJ-VWDRLOGHSA-N",
    "display_name": "SONIDEGIB PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "028312dc-d155-4fd5-8abd-6bb9f011d3cc": {
      "match": "brand_token",
      "title": "ODOMZO (SONIDEGIB) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "14",
      "published_date": "2025-01-03"
    }
  },
  "productid": "47335-303_001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3",
  "productndc": "47335-303",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205266",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Jul 24, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SONIDEGIB PHOSPHATE",
  "proprietary_name": "Odomzo",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205266",
  "marketing_category": "NDA",
  "nonproprietary_name": "sonidegib",
  "start_marketing_date": "20170921",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code L01XJ02.

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