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United States · US · US:49702-202_42a6587e-9322-4810-8c72-1dc40f3543d2

COMBIVIR

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970220218
    60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18)

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
N020857
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": {
    "16da660b-9981-4d24-a14a-94c7744fce4f": {
      "match": "brand_token",
      "title": "COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]",
      "spl_version": "22",
      "published_date": "2024-10-03"
    }
  },
  "productid": "49702-202_42a6587e-9322-4810-8c72-1dc40f3543d2",
  "productndc": "49702-202",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020857",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Sep 26, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE; ZIDOVUDINE",
  "proprietary_name": "COMBIVIR",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020857",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamivudine and zidovudine",
  "start_marketing_date": "20101019",
  "active_numerator_strength": "150; 300"
}

Related drugs

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