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United States · US · US:0069-0334_09443f87-c2da-46a4-99f0-af020d1acdb4
Litfulo
Orange BookUNIISPLATC L04AF08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeL04AF08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006903342828 CAPSULE in 1 BOTTLE (0069-0334-28)
Annotations
UNII (FDA Substance ID)
EAG4T1459K
RITLECITINIB TOSYLATE
Orange Book
N215830
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "EAG4T1459K",
"rxcui": null,
"inchikey": "YOZLVAFWYLSRRN-VZXYPILPSA-N",
"display_name": "RITLECITINIB TOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6b2f9446-fb23-4741-b73a-5a2f993733c3": {
"match": "brand_token",
"title": "LITFULO (RITLECITINIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "5",
"published_date": "2026-05-28"
}
},
"productid": "0069-0334_09443f87-c2da-46a4-99f0-af020d1acdb4",
"productndc": "0069-0334",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215830",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Jun 23, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RITLECITINIB TOSYLATE",
"proprietary_name": "Litfulo",
"active_ingred_unit": "mg/1",
"application_number": "NDA215830",
"marketing_category": "NDA",
"nonproprietary_name": "ritlecitinib",
"start_marketing_date": "20230706",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L04AF08.
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