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United States · US · US:42385-962_e6dbfbf4-1917-4764-a6b2-e3da98aa5620

Abacavir and Lamivudine

Orange BookUNIISPLATC J05AF

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

Identification

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

Packs · 3

  • ndc11
    4238596218
    180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18)
  • ndc11
    4238596230
    30 TABLET, FILM COATED in 1 BOTTLE (42385-962-30)
  • ndc11
    4238596290
    90 TABLET, FILM COATED in 1 BOTTLE (42385-962-90)

Annotations

UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A216332
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": "42385-962_e6dbfbf4-1917-4764-a6b2-e3da98aa5620",
  "productndc": "42385-962",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216332",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 600MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Jul 25, 2022"
      }
    ],
    "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": "ANDA216332",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Abacavir and Lamivudine",
  "start_marketing_date": "20220725",
  "active_numerator_strength": "600; 300"
}

Related drugs

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