Teriflunomide

Orange BookUNIISPLATC L04AK02

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

Identification

ManufacturerMSN LABORATORIES PRIVATE LIMITED

CountryUS (United States)

ATC codeL04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6953931630
30 TABLET, FILM COATED in 1 BOTTLE (69539-316-30)
ndc11
6953931641
2 BLISTER PACK in 1 CARTON (69539-316-41) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

1C058IKG3B

TERIFLUNOMIDE

RxCUI 1310520

Orange Book

A209623

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": "69539-316_3b178225-b3ba-4c9f-bde6-a5e076697980",
  "productndc": "69539-316",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209623",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Apr 24, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Apr 24, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIFLUNOMIDE",
  "proprietary_name": "Teriflunomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209623",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Teriflunomide",
  "start_marketing_date": "20190424",
  "active_numerator_strength": "14"
}

Related drugs

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