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United States · US · US:64980-351_edd6ee53-72b7-48e5-aef4-30c077db7545

Famciclovir

Orange BookUNIISPLATC J05AB09

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeJ05AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6498035103
    30 TABLET, FILM COATED in 1 BOTTLE (64980-351-03)

Annotations

UNII (FDA Substance ID)
QIC03ANI02
FAMCICLOVIR
RxCUI 68099
Orange Book
A091114
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": "64980-351_edd6ee53-72b7-48e5-aef4-30c077db7545",
  "productndc": "64980-351",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Mar 21, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Mar 21, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Mar 21, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMCICLOVIR",
  "proprietary_name": "Famciclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famciclovir",
  "start_marketing_date": "20110321",
  "active_numerator_strength": "500"
}

Related drugs

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