Teriflunomide

Orange BookUNIISPLATC L04AK02

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378062893
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0628-93)

Annotations

UNII (FDA Substance ID)

1C058IKG3B

TERIFLUNOMIDE

RxCUI 1310520

Orange Book

A209702

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": "0378-0628_1824aae5-58af-43da-8231-435c8f118bc0",
  "productndc": "0378-0628",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209702",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIFLUNOMIDE",
  "proprietary_name": "Teriflunomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209702",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Teriflunomide",
  "start_marketing_date": "20230214",
  "active_numerator_strength": "14"
}

Related drugs

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