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United States · US · US:43063-589_509f352e-407a-d52b-e063-6294a90a696a
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11430635891010 TABLET in 1 BOTTLE, PLASTIC (43063-589-10)
- ndc11430635893030 TABLET in 1 BOTTLE, PLASTIC (43063-589-30)
- ndc11430635893535 TABLET in 1 BOTTLE, PLASTIC (43063-589-35)
- ndc11430635895050 TABLET in 1 BOTTLE, PLASTIC (43063-589-50)
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": "43063-589_509f352e-407a-d52b-e063-6294a90a696a",
"productndc": "43063-589",
"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": "800"
}Related drugs
Other records sharing ATC code J05AB01.
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