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United States · US · US:60687-867_4a03039d-ae31-10ea-e063-6294a90a1e30

ACYCLOVIR

Orange BookUNIISPLATC J05AB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068786701
    100 BLISTER PACK in 1 CARTON (60687-867-01) / 1 TABLET in 1 BLISTER PACK (60687-867-11)

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A074891
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": "60687-867_4a03039d-ae31-10ea-e063-6294a90a1e30",
  "productndc": "60687-867",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074891",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Oct 31, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Oct 31, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "ACYCLOVIR",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074891",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ACYCLOVIR",
  "start_marketing_date": "20250606",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code J05AB01.

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