🇺🇸
United States · US · US:42799-970_aefbcc7a-bc7a-4cd6-a0d4-a47ae8cdd877
Tofacitinib
Orange BookUNIISPLATC L04AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeL04AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11427999703030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42799-970-30)
Annotations
UNII (FDA Substance ID)
O1FF4DIV0D
TOFACITINIB CITRATE
RxCUI 1358492
Orange Book
A218668
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": "42799-970_aefbcc7a-bc7a-4cd6-a0d4-a47ae8cdd877",
"productndc": "42799-970",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "218668",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 11MG BASE",
"product_no": "001",
"approval_date": "Dec 16, 2024"
}
],
"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": "ANDA218668",
"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 Lifesciences Limited
Access this data programmatically
Query Tofacitinib and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.