Famciclovir

Orange BookUNIISPLATC J05AB09

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeJ05AB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4229141530
30 TABLET, FILM COATED in 1 BOTTLE (42291-415-30)

Annotations

UNII (FDA Substance ID)

QIC03ANI02

FAMCICLOVIR

RxCUI 68099

Orange Book

A077487

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QIC03ANI02",
    "rxcui": "68099",
    "inchikey": "GGXKWVWZWMLJEH-UHFFFAOYSA-N",
    "display_name": "FAMCICLOVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "96259999-3166-40bb-953f-1a901c84749e": {
      "match": "brand_token",
      "title": "FAMCICLOVIR POWDER [EVEREEN SHANGHAI BIOTECHNOLOGY LTD.]",
      "spl_version": "1",
      "published_date": "2026-03-20"
    }
  },
  "productid": "42291-415_485cfe40-2ff0-e83f-e063-6394a90a221c",
  "productndc": "42291-415",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077487",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Aug 24, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Aug 24, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Aug 24, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMCICLOVIR",
  "proprietary_name": "Famciclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077487",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famciclovir",
  "start_marketing_date": "20210519",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J05AB09.

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