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United States · US · US:33342-024_b783e311-5fb2-4ab3-b10a-36c87c2a7d5f

Famciclovir

Orange BookUNIISPLATC J05AB09

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3334202407
    30 TABLET, FILM COATED in 1 BOTTLE (33342-024-07)

Annotations

UNII (FDA Substance ID)
QIC03ANI02
FAMCICLOVIR
RxCUI 68099
Orange Book
A201022
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": "33342-024_b783e311-5fb2-4ab3-b10a-36c87c2a7d5f",
  "productndc": "33342-024",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201022",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Jan 12, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Jan 12, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Jan 12, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMCICLOVIR",
  "proprietary_name": "Famciclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201022",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famciclovir",
  "start_marketing_date": "20120113",
  "active_numerator_strength": "125"
}

Related drugs

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