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United States · US · US:70377-057_abb2bd0f-2de5-6ca1-6f9a-84a65a1c131d
Tofacitinib
Orange BookUNIISPLATC L04AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiocon Pharma Inc
CountryUS (United States)
ATC codeL04AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11703770571130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11)
Annotations
UNII (FDA Substance ID)
O1FF4DIV0D
TOFACITINIB CITRATE
RxCUI 1358492
Orange Book
A219442
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "O1FF4DIV0D",
"rxcui": "1358492",
"inchikey": "SYIKUFDOYJFGBQ-YLAFAASESA-N",
"display_name": "TOFACITINIB CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ac0b26d5-1352-42ff-b5ea-3eb02d8508a4": {
"match": "brand_token",
"title": "TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]",
"spl_version": "5",
"published_date": "2026-05-21"
}
},
"productid": "70377-057_abb2bd0f-2de5-6ca1-6f9a-84a65a1c131d",
"productndc": "70377-057",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "219442",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 11MG BASE",
"product_no": "001",
"approval_date": "Nov 17, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOFACITINIB CITRATE",
"proprietary_name": "Tofacitinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219442",
"marketing_category": "ANDA",
"nonproprietary_name": "Tofacitinib",
"start_marketing_date": "20260603",
"active_numerator_strength": "11"
}Related drugs
Other records sharing ATC code L04AF01.
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- CAJAMP TOFACITINIBJAMP PHARMA CORPORATION
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- 🇺🇸tofacitinibZydus Lifesciences Limited
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