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United States · US · US:49702-205_3d326658-e562-4d27-a0ad-ca2017db2e49

EPIVIR

Orange BookUNIISPLATC J05AF05

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

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AF05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970220548
    240 mL in 1 BOTTLE (49702-205-48)

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
N020596
AA
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": {
    "89226149-47fa-4f7d-bb1f-1aa7034486b8": {
      "match": "brand_token",
      "title": "EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]",
      "spl_version": "23",
      "published_date": "2025-09-25"
    }
  },
  "productid": "49702-205_3d326658-e562-4d27-a0ad-ca2017db2e49",
  "productndc": "49702-205",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "020596",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Nov 17, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE",
  "proprietary_name": "EPIVIR",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020596",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamivudine",
  "start_marketing_date": "20101004",
  "active_numerator_strength": "10"
}

Related drugs

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