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United States · US · US:68788-8203_67f406ad-9398-4613-a77a-439966f1d0ae
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116878882031100 TABLET in 1 BOTTLE (68788-8203-1)
- ndc11687888203221 TABLET in 1 BOTTLE (68788-8203-2)
- ndc11687888203330 TABLET in 1 BOTTLE (68788-8203-3)
- ndc11687888203440 TABLET in 1 BOTTLE (68788-8203-4)
- ndc11687888203550 TABLET in 1 BOTTLE (68788-8203-5)
- ndc11687888203835 TABLET in 1 BOTTLE (68788-8203-8)
Annotations
UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A209366
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": "68788-8203_67f406ad-9398-4613-a77a-439966f1d0ae",
"productndc": "68788-8203",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209366",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Oct 7, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Oct 7, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR",
"proprietary_name": "Acyclovir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209366",
"marketing_category": "ANDA",
"nonproprietary_name": "Acyclovir",
"start_marketing_date": "20220526",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AB01.
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