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United States · US · US:69097-514_cf84089d-b713-40b8-a815-b66f4119982e

Abacavir

Orange BookUNIISPLATC J05AF06

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeJ05AF06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6909751403
    60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)

Annotations

UNII (FDA Substance ID)
J220T4J9Q2
ABACAVIR SULFATE
RxCUI 221052
Orange Book
A078119
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": "69097-514_cf84089d-b713-40b8-a815-b66f4119982e",
  "productndc": "69097-514",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078119",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "001",
        "approval_date": "Nov 21, 2017"
      }
    ],
    "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": "ANDA078119",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Abacavir",
  "start_marketing_date": "20171121",
  "active_numerator_strength": "300"
}

Related drugs

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