Aubagio

Orange BookUNIISPLATC L04AK02

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

Identification

ManufacturerGenzyme Corporation

CountryUS (United States)

ATC codeL04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5846802101
1 BLISTER PACK in 1 CARTON (58468-0210-1) / 5 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5846802103
1 BLISTER PACK in 1 CARTON (58468-0210-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5846802104
1 BOTTLE in 1 CARTON (58468-0210-4) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

1C058IKG3B

TERIFLUNOMIDE

RxCUI 1310520

Orange Book

N202992

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": {
    "4650d12c-b9c8-4525-b07f-a2d773eca155": {
      "match": "brand_token",
      "title": "AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORPORATION]",
      "spl_version": "28",
      "published_date": "2026-02-25"
    }
  },
  "productid": "58468-0210_fafc0928-a014-4dfc-8f46-e0d8aa6690bc",
  "productndc": "58468-0210",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202992",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "7MG",
        "product_no": "001",
        "approval_date": "Sep 12, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "14MG",
        "product_no": "002",
        "approval_date": "Sep 12, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIFLUNOMIDE",
  "proprietary_name": "Aubagio",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202992",
  "marketing_category": "NDA",
  "nonproprietary_name": "teriflunomide",
  "start_marketing_date": "20130501",
  "active_numerator_strength": "14"
}

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