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United States · US · US:54348-627_ea937906-dba1-207f-e053-2a95a90a111e
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmPak, Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1154348627101 BOTTLE in 1 BOX (54348-627-10) / 10 TABLET in 1 BOTTLE
- ndc1154348627151 BOTTLE in 1 BOX (54348-627-15) / 15 TABLET in 1 BOTTLE
- ndc1154348627201 BOTTLE in 1 BOX (54348-627-20) / 20 TABLET in 1 BOTTLE
- ndc1154348627211 BOTTLE in 1 BOX (54348-627-21) / 21 TABLET in 1 BOTTLE
- ndc1154348627251 BOTTLE in 1 BOX (54348-627-25) / 25 TABLET in 1 BOTTLE
- ndc1154348627301 BOTTLE in 1 BOX (54348-627-30) / 30 TABLET in 1 BOTTLE
- ndc1154348627601 BOTTLE in 1 BOX (54348-627-60) / 60 TABLET in 1 BOTTLE
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": "54348-627_ea937906-dba1-207f-e053-2a95a90a111e",
"productndc": "54348-627",
"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": "20131129",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AB01.
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