TERIFLUNOMIDE

Orange BookUNIISPLATC L04AK02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCONCORD BIOTECH LIMITED

CountryUS (United States)

ATC codeL04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6825450091
30 TABLET, FILM COATED in 1 BOTTLE (68254-5009-1)

Annotations

UNII (FDA Substance ID)

1C058IKG3B

TERIFLUNOMIDE

RxCUI 1310520

Orange Book

A218663

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1C058IKG3B",
    "rxcui": "1310520",
    "inchikey": "UTNUDOFZCWSZMS-YFHOEESVSA-N",
    "display_name": "TERIFLUNOMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8c1bc23b-a62b-4172-a603-8b97761514b4": {
      "match": "brand_token",
      "title": "TERIFLUNOMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]",
      "spl_version": "18",
      "published_date": "2026-05-20"
    }
  },
  "productid": "68254-5009_ebb5a19c-6889-4d12-b9fd-b7dea06a52d0",
  "productndc": "68254-5009",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218663",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Apr 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Apr 7, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIFLUNOMIDE",
  "proprietary_name": "TERIFLUNOMIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TERIFLUNOMIDE",
  "start_marketing_date": "20250707",
  "active_numerator_strength": "7"
}

Related drugs

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