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United States · US · US:27241-270_898673f3-2ca9-44ee-b4bd-c9c65809bd83
Tofacitinib
Orange BookUNIISPLATC L04AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeL04AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11272412703030 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-270-30)
Annotations
UNII (FDA Substance ID)
O1FF4DIV0D
TOFACITINIB CITRATE
RxCUI 1358492
Orange Book
A219542
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": "27241-270_898673f3-2ca9-44ee-b4bd-c9c65809bd83",
"productndc": "27241-270",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "219542",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 11MG BASE",
"product_no": "001",
"approval_date": "Aug 19, 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": "ANDA219542",
"marketing_category": "ANDA",
"nonproprietary_name": "Tofacitinib",
"start_marketing_date": "20260603",
"active_numerator_strength": "11"
}Related drugs
Other records sharing ATC code L04AF01.
- CAAURO-TOFACITINIBAURO PHARMA INC
- CAAURO-TOFACITINIBAURO PHARMA INC
- CAJAMP TOFACITINIBJAMP PHARMA CORPORATION
- CAPMS-TOFACITINIBPHARMASCIENCE INC
- CATARO-TOFACITINIBTARO PHARMACEUTICALS INC
- CATARO-TOFACITINIBTARO PHARMACEUTICALS INC
- CATARO-TOFACITINIB XRTARO PHARMACEUTICALS INC
- 🇺🇸tofacitinibZydus Pharmaceuticals USA Inc.
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