ABACAVIR and LAMIVUDINE

Orange BookUNIISPLATC J05AF

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3172283830
1 BOTTLE in 1 CARTON (31722-838-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

J220T4J9Q2

ABACAVIR SULFATE

RxCUI 221052

Orange Book

A205412

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": "31722-838_366cb4c4-0386-17b7-e063-6394a90a5fd1",
  "productndc": "31722-838",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 600MG BASE;300MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2025"
      }
    ],
    "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": "ANDA205412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ABACAVIR and LAMIVUDINE",
  "start_marketing_date": "20250416",
  "active_numerator_strength": "600; 300"
}

Related drugs

Other records sharing ATC code J05AF.

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