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United States · US · US:0904-6583_ccee4284-79ab-43d8-a282-d0bb93818389

LAMIVUDINE

Orange BookUNIISPLATC J05AF05

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeJ05AF05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0904658304
    30 BLISTER PACK in 1 CARTON (0904-6583-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
A091606
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": "0904-6583_ccee4284-79ab-43d8-a282-d0bb93818389",
  "productndc": "0904-6583",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091606",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Dec 2, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 2, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE",
  "proprietary_name": "LAMIVUDINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091606",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lamivudine",
  "start_marketing_date": "20111202",
  "active_numerator_strength": "150"
}

Related drugs

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