Lamivudine and Zidovudine

Orange BookUNIISPLATC J05AF

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3334200309
60 TABLET in 1 BOTTLE (33342-003-09)

Annotations

UNII (FDA Substance ID)

2T8Q726O95

LAMIVUDINE

RxCUI 68244

Orange Book

A090679

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": "33342-003_c28a7cc4-0638-4fc2-a549-a87887e8d50e",
  "productndc": "33342-003",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090679",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG;300MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2018"
      }
    ],
    "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": "ANDA090679",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamivudine and Zidovudine",
  "start_marketing_date": "20180830",
  "active_numerator_strength": "150; 300"
}

Related drugs

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