ABACAVIR, LAMIVUDINE AND ZIDOVUDINE

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

J220T4J9Q2

ABACAVIR SULFATE

RxCUI 221052

Orange Book

A202912

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "J220T4J9Q2",
    "rxcui": "221052",
    "inchikey": "WMHSRBZIJNQHKT-FFKFEZPRSA-N",
    "display_name": "ABACAVIR SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f5f7c0d9-a247-4308-8269-32accc490ea6": {
      "match": "brand_token",
      "title": "ABACAVIR, LAMIVUDINE AND ZIDOVUDINE (ABACAVIR , LAMIVUDINE AND ZIDOVUDINE) TABLET [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2023-11-02"
    }
  },
  "productid": "68180-286_e180b9ff-1e7c-422a-9fe7-afd39eee3e4e",
  "productndc": "68180-286",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 300MG BASE;150MG;300MG",
        "product_no": "001",
        "approval_date": "Dec 5, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE",
  "proprietary_name": "ABACAVIR, LAMIVUDINE AND ZIDOVUDINE",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA202912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ABACAVIR , LAMIVUDINE AND ZIDOVUDINE",
  "start_marketing_date": "20131217",
  "active_numerator_strength": "300; 150; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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