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United States · US · US:60505-3247_4c5bca9f-f6ee-57ce-1894-b84a21162b7e
FAMCICLOVIR
Orange BookUNIISPLATC J05AB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeJ05AB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11605053247330 TABLET, FILM COATED in 1 BOTTLE (60505-3247-3)
Annotations
UNII (FDA Substance ID)
QIC03ANI02
FAMCICLOVIR
RxCUI 68099
Orange Book
A091480
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": "60505-3247_4c5bca9f-f6ee-57ce-1894-b84a21162b7e",
"productndc": "60505-3247",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091480",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG",
"product_no": "001",
"approval_date": "Jul 22, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "002",
"approval_date": "Jul 22, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "003",
"approval_date": "Jul 22, 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": "ANDA091480",
"marketing_category": "ANDA",
"nonproprietary_name": "FAMCICLOVIR",
"start_marketing_date": "20111220",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J05AB09.
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