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United States · US · US:48102-028_8b20bece-92d7-4715-aad0-6eddba900c2c
Avaclyr
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1148102028351 TUBE in 1 CARTON (48102-028-35) / 3.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
N202408
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X4HES1O11F",
"rxcui": "281",
"inchikey": "MKUXAQIIEYXACX-UHFFFAOYSA-N",
"display_name": "ACYCLOVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"3ce26231-bc40-48b0-85e5-2e7622f334d7": {
"match": "brand_token",
"title": "AVACLYR (ACYCLOVIR) OINTMENT [FERA PHARMACEUTICALS, LLC]",
"spl_version": "3",
"published_date": "2026-02-02"
}
},
"productid": "48102-028_8b20bece-92d7-4715-aad0-6eddba900c2c",
"productndc": "48102-028",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "202408",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Mar 29, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR",
"proprietary_name": "Avaclyr",
"active_ingred_unit": "mg/g",
"application_number": "NDA202408",
"marketing_category": "NDA",
"nonproprietary_name": "ACYCLOVIR",
"start_marketing_date": "20260131",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code J05AB01.
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