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United States · US · US:68382-049_515388e8-636f-42f6-a39e-bb4fc7c2e7cb
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 · 1
- ndc11683820491010 VIAL, SINGLE-USE in 1 CARTON (68382-049-10) / 20 mL in 1 VIAL, SINGLE-USE (68382-049-01)
Annotations
UNII (FDA Substance ID)
927L42J563
ACYCLOVIR SODIUM
RxCUI 81944
Orange Book
A206535
AP
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": "68382-049_515388e8-636f-42f6-a39e-bb4fc7c2e7cb",
"productndc": "68382-049",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206535",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG BASE/ML",
"product_no": "001",
"approval_date": "Aug 31, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACYCLOVIR SODIUM",
"proprietary_name": "acyclovir",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206535",
"marketing_category": "ANDA",
"nonproprietary_name": "ACYCLOVIR",
"start_marketing_date": "20181127",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J05AB01.
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