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United States · US · US:49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855

CIMDUO

Orange BookUNIISPLATC J05AF

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4950245093
    1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
N022141
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2T8Q726O95",
    "rxcui": "68244",
    "inchikey": "JTEGQNOMFQHVDC-NKWVEPMBSA-N",
    "display_name": "LAMIVUDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a300f04d-118f-4136-aaf3-ddfd00197f86": {
      "match": "brand_token",
      "title": "CIMDUO (LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]",
      "spl_version": "5",
      "published_date": "2025-02-10"
    }
  },
  "productid": "49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855",
  "productndc": "49502-450",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022141",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG;300MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "CIMDUO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022141",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lamivudine and Tenofovir Disoproxil Fumarate",
  "start_marketing_date": "20180625",
  "active_numerator_strength": "300; 300"
}

Related drugs

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