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United States · US · US:33342-439_49a1e24d-5821-45a5-bf2f-0497f4fd3a1b
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1133342439151 TUBE in 1 CARTON (33342-439-15) / 15 g in 1 TUBE
- ndc1133342439301 TUBE in 1 CARTON (33342-439-30) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A212444
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": "33342-439_49a1e24d-5821-45a5-bf2f-0497f4fd3a1b",
"productndc": "33342-439",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "212444",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "May 19, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR",
"proprietary_name": "Acyclovir",
"active_ingred_unit": "mg/g",
"application_number": "ANDA212444",
"marketing_category": "ANDA",
"nonproprietary_name": "Acyclovir",
"start_marketing_date": "20180813",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB01.
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