LAMIVUDINE and ZIDOVUDINE

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306390006
6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-900-06)

Annotations

UNII (FDA Substance ID)

2T8Q726O95

LAMIVUDINE

RxCUI 68244

Orange Book

A079124

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": "43063-900_415d1735-9f33-0e91-e063-6394a90a16de",
  "productndc": "43063-900",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079124",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG;300MG",
        "product_no": "001",
        "approval_date": "Sep 17, 2015"
      }
    ],
    "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": "ANDA079124",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LAMIVUDINE and ZIDOVUDINE",
  "start_marketing_date": "20150918",
  "active_numerator_strength": "150; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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