Teriflunomide

Orange BookUNIISPLATC L04AK02

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

Identification

ManufacturerNatco Pharma USA LLC

CountryUS (United States)

ATC codeL04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6933916903
30 TABLET in 1 BOTTLE (69339-169-03)
ndc11
6933916909
90 TABLET in 1 BOTTLE (69339-169-09)
ndc11
6933916993
2 BLISTER PACK in 1 CARTON (69339-169-93) / 30 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

1C058IKG3B

TERIFLUNOMIDE

RxCUI 1310520

Orange Book

A209555

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": "69339-169_70bc9344-abbf-4aca-96c0-7f10cfe9aae4",
  "productndc": "69339-169",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209555",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "May 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "May 15, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIFLUNOMIDE",
  "proprietary_name": "Teriflunomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209555",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Teriflunomide",
  "start_marketing_date": "20230617",
  "active_numerator_strength": "7"
}

Related drugs

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