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United States · US · US:13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20
Sorafenib
Orange BookUNIISPLATC L01EX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeL01EX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111366868212120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12)
- ndc11136686823030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30)
- ndc11136686826060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60)
- ndc11136686827410 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9ZOQ3TZI87
SORAFENIB
RxCUI 495881
Orange Book
A217095
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": "13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20",
"productndc": "13668-682",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217095",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Apr 12, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SORAFENIB",
"proprietary_name": "Sorafenib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217095",
"marketing_category": "ANDA",
"nonproprietary_name": "sorafenib",
"start_marketing_date": "20230412",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01EX02.
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