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United States · US · US:65162-835_5701d6c5-b948-4d7b-ab6e-99b5c559dbf5
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165162835941 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE
- ndc1165162835961 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A204605
AB
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": "TOPICAL",
"spl_meta": {
"db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0": {
"match": "brand_token",
"title": "ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "19",
"published_date": "2026-05-28"
}
},
"productid": "65162-835_5701d6c5-b948-4d7b-ab6e-99b5c559dbf5",
"productndc": "65162-835",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "204605",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Jun 18, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR",
"proprietary_name": "Acyclovir",
"active_ingred_unit": "mg/g",
"application_number": "ANDA204605",
"marketing_category": "ANDA",
"nonproprietary_name": "Acyclovir",
"start_marketing_date": "20140103",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB01.
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