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United States · US · US:68071-3222_1cc108f1-2752-1fed-e063-6394a90a7e9f

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6807132220
    50 TABLET in 1 BOTTLE (68071-3222-0)
  • ndc11
    6807132221
    21 TABLET in 1 BOTTLE (68071-3222-1)
  • ndc11
    6807132222
    25 TABLET in 1 BOTTLE (68071-3222-2)
  • ndc11
    6807132223
    30 TABLET in 1 BOTTLE (68071-3222-3)
  • ndc11
    6807132224
    14 TABLET in 1 BOTTLE (68071-3222-4)
  • ndc11
    6807132225
    35 TABLET in 1 BOTTLE (68071-3222-5)
  • ndc11
    6807132227
    15 TABLET in 1 BOTTLE (68071-3222-7)

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": "68071-3222_1cc108f1-2752-1fed-e063-6394a90a7e9f",
  "productndc": "68071-3222",
  "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

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