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United States · US · US:68382-791_d8791a7b-225c-4f2e-9023-1a1932b0f7d7
acyclovir
Orange BookUNIISPLATC J05AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838279101100 TABLET in 1 BOTTLE (68382-791-01)
- ndc116838279105500 TABLET in 1 BOTTLE (68382-791-05)
- ndc11683827910630 TABLET in 1 BOTTLE (68382-791-06)
- ndc1168382791101000 TABLET in 1 BOTTLE (68382-791-10)
- ndc11683827911690 TABLET in 1 BOTTLE (68382-791-16)
- ndc11683827913010 BLISTER PACK in 1 CARTON (68382-791-30) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A204314
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": "68382-791_d8791a7b-225c-4f2e-9023-1a1932b0f7d7",
"productndc": "68382-791",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204314",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Aug 19, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Aug 19, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR",
"proprietary_name": "acyclovir",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204314",
"marketing_category": "ANDA",
"nonproprietary_name": "acyclovir",
"start_marketing_date": "20140910",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AB01.
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