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United States · US · US:65862-026_0c6a0ca4-d63c-4018-909a-d9e7a2821ed4

Lamivudine

Orange BookUNIISPLATC J05AF05

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AF05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6586202610
    3 BLISTER PACK in 1 CARTON (65862-026-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6586202630
    30 TABLET, FILM COATED in 1 BOTTLE (65862-026-30)

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
A077464
ABAB
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": {
    "6fd4d6b9-65ea-4988-8d6f-dd220ec5052d": {
      "match": "brand_token",
      "title": "LAMIVUDINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]",
      "spl_version": "5",
      "published_date": "2026-03-20"
    }
  },
  "productid": "65862-026_0c6a0ca4-d63c-4018-909a-d9e7a2821ed4",
  "productndc": "65862-026",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077464",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE",
  "proprietary_name": "Lamivudine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077464",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamivudine",
  "start_marketing_date": "20161121",
  "active_numerator_strength": "300"
}

Related drugs

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