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United States · US · US:68084-021_1ea3a366-c7c0-2e89-e063-6294a90a2419

Abacavir

Orange BookUNIISPLATC J05AF06

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeJ05AF06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808402121
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-021-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-021-11)

Annotations

UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A077844
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": "68084-021_1ea3a366-c7c0-2e89-e063-6294a90a2419",
  "productndc": "68084-021",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077844",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "001",
        "approval_date": "Dec 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABACAVIR SULFATE",
  "proprietary_name": "Abacavir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077844",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Abacavir",
  "start_marketing_date": "20130204",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J05AF06.

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