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United States · US · US:0143-9658_dbf69540-34d6-423d-a06a-e5eddfd40ae3
Acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014396581010 VIAL, SINGLE-DOSE in 1 BOX (0143-9658-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9658-01)
Annotations
UNII (FDA Substance ID)
927L42J563
ACYCLOVIR SODIUM
RxCUI 81944
Orange Book
A205771
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "927L42J563",
"rxcui": "81944",
"inchikey": "RMLUKZWYIKEASN-UHFFFAOYSA-M",
"display_name": "ACYCLOVIR SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"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": "0143-9658_dbf69540-34d6-423d-a06a-e5eddfd40ae3",
"productndc": "0143-9658",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "205771",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Feb 29, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 1GM BASE/VIAL",
"product_no": "002",
"approval_date": "Feb 29, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR SODIUM",
"proprietary_name": "Acyclovir",
"active_ingred_unit": "g/1",
"application_number": "ANDA205771",
"marketing_category": "ANDA",
"nonproprietary_name": "Acyclovir",
"start_marketing_date": "20160229",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J05AB01.
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