Famciclovir

Orange BookUNIISPLATC J05AB09

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeJ05AB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6586246630
30 TABLET, FILM COATED in 1 BOTTLE (65862-466-30)
ndc11
6586246650
5 BLISTER PACK in 1 CARTON (65862-466-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6586246699
1000 TABLET, FILM COATED in 1 BOTTLE (65862-466-99)

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": "65862-466_c372e46a-af0b-43c2-8f33-d20e4c6e27d5",
  "productndc": "65862-466",
  "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": "250"
}

Related drugs

Other records sharing ATC code J05AB09.

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