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United States · US · US:65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099

Abacavir and Lamivudine

Orange BookUNIISPLATC J05AF

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

Identification

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

Packs · 2

  • ndc11
    6586233510
    10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6586233530
    1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A090159
AB
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": "65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099",
  "productndc": "65862-335",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090159",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 600MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Nov 15, 2018"
      }
    ],
    "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": "ANDA090159",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Abacavir and Lamivudine",
  "start_marketing_date": "20181115",
  "active_numerator_strength": "600; 300"
}

Related drugs

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