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United States · US · US:33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352

Abacavir and Lamivudine

Orange BookUNIISPLATC J05AF

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

Identification

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

Packs · 3

  • ndc11
    3334244007
    30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07)
  • ndc11
    3334244014
    5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)
  • ndc11
    3334244098
    10 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)

Annotations

UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A212663
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": {
    "4b286ec6-68a7-4ec0-af07-5a27ec9cb35d": {
      "match": "brand_token",
      "title": "ABACAVIR TABLET, FILM COATED [MAJOR PHARMACEUTICALS]",
      "spl_version": "6",
      "published_date": "2026-03-18"
    }
  },
  "productid": "33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352",
  "productndc": "33342-440",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212663",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 600MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABACAVIR SULFATE; LAMIVUDINE",
  "proprietary_name": "Abacavir and Lamivudine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA212663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Abacavir and Lamivudine",
  "start_marketing_date": "20241220",
  "active_numerator_strength": "600; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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