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United States · US · US:0904-7507_a5909f5b-fb25-4050-990a-19d29eef0457
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110904750761100 BLISTER PACK in 1 CARTON (0904-7507-61) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A203834
ABAB
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": "ORAL",
"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": "0904-7507_a5909f5b-fb25-4050-990a-19d29eef0457",
"productndc": "0904-7507",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203834",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Oct 29, 2013"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Oct 29, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR",
"proprietary_name": "Acyclovir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203834",
"marketing_category": "ANDA",
"nonproprietary_name": "Acyclovir",
"start_marketing_date": "20250128",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AB01.
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