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United States · US · US:65219-826_6d4382de-5c0c-4603-b7e0-40acb62f9368
Otulfi
UNIISPLATC L04AC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL04AC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165219826261 SYRINGE in 1 CARTON (65219-826-26) / 1 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
FU77B4U5Z0
USTEKINUMAB
RxCUI 847083
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FU77B4U5Z0",
"rxcui": "847083",
"inchikey": null,
"display_name": "USTEKINUMAB",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"853130e5-7406-4fd6-8138-ff2179195927": {
"match": "brand_token",
"title": "OTULFI (USTEKINUMAB-AAUZ) INJECTION, SOLUTION OTULFI (USTEKINUMAB-AAUZ) SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "4",
"published_date": "2026-03-23"
}
},
"productid": "65219-826_6d4382de-5c0c-4603-b7e0-40acb62f9368",
"productndc": "65219-826",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "USTEKINUMAB",
"proprietary_name": "Otulfi",
"active_ingred_unit": "mg/mL",
"application_number": "BLA761379",
"marketing_category": "BLA",
"nonproprietary_name": "ustekinumab-aauz",
"start_marketing_date": "20240222",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code L04AC05.
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