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United States · US · US:76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04

Lamivudine and Zidovudine

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerExelan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7628211505
    500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05)
  • ndc11
    7628211560
    60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60)

Annotations

UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
A203259
AB
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": "76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04",
  "productndc": "76282-115",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203259",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG;300MG",
        "product_no": "001",
        "approval_date": "Feb 3, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMIVUDINE; ZIDOVUDINE",
  "proprietary_name": "Lamivudine and Zidovudine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203259",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamivudine and Zidovudine",
  "start_marketing_date": "20150429",
  "active_numerator_strength": "150; 300"
}

Related drugs

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