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United States · US · US:63187-998_f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4

Famciclovir

Orange BookUNIISPLATC J05AB09

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ05AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6318799821
    21 TABLET, FILM COATED in 1 BOTTLE (63187-998-21)
  • ndc11
    6318799830
    30 TABLET, FILM COATED in 1 BOTTLE (63187-998-30)
  • ndc11
    6318799860
    60 TABLET, FILM COATED in 1 BOTTLE (63187-998-60)
  • ndc11
    6318799890
    90 TABLET, FILM COATED in 1 BOTTLE (63187-998-90)

Annotations

UNII (FDA Substance ID)
QIC03ANI02
FAMCICLOVIR
RxCUI 68099
Orange Book
A202438
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": "63187-998_f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4",
  "productndc": "63187-998",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202438",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Sep 10, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Sep 10, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Sep 10, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMCICLOVIR",
  "proprietary_name": "Famciclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202438",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famciclovir",
  "start_marketing_date": "20140910",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J05AB09.

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