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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

  • ndc11
    4279997030
    30 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

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