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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
- ndc11473353031530 CAPSULE in 1 BOTTLE (47335-303-15)
- ndc11473353038330 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.
- ISOdomzoSun Pharmaceutical Industries Europe B.V.*
- 🇨🇭Odomzo
- PLOdomzoSun Pharmaceutical Industries Europe B.V.
- 🇨🇭OdomzoSun Pharma Switzerland Ltd
- DKOdomzoSUN Pharmaceutical Industries Europe BV
- NOOdomzoSun Pharmaceutical - Nederland
- FIOdomzoSun Pharmaceutical Industries Europe B.V.
- CAODOMZOSUN PHARMACEUTICAL INDUSTRIES LIMITED
Access this data programmatically
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