teriflunomide

Orange BookUNIISPLATC L04AK02

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeL04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6846242315
2 BLISTER PACK in 1 CARTON (68462-423-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6846242330
30 TABLET, FILM COATED in 1 BOTTLE (68462-423-30)
ndc11
6846242385
1 BLISTER PACK in 1 CARTON (68462-423-85) / 5 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

1C058IKG3B

TERIFLUNOMIDE

RxCUI 1310520

Orange Book

A209663

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": "68462-423_d53d13f1-99cc-4ba3-b1e5-a2781fe6564a",
  "productndc": "68462-423",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209663",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Nov 15, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Nov 15, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIFLUNOMIDE",
  "proprietary_name": "teriflunomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "teriflunomide",
  "start_marketing_date": "20230119",
  "active_numerator_strength": "7"
}

Related drugs

Other records sharing ATC code L04AK02.

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