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United States · US · US:68788-7575_9248c792-3664-4f8e-9d1d-3c4344deb9fc

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

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

Packs · 7

  • ndc11
    6878875752
    21 TABLET in 1 BOTTLE (68788-7575-2)
  • ndc11
    6878875753
    30 TABLET in 1 BOTTLE (68788-7575-3)
  • ndc11
    6878875754
    40 TABLET in 1 BOTTLE (68788-7575-4)
  • ndc11
    6878875755
    50 TABLET in 1 BOTTLE (68788-7575-5)
  • ndc11
    6878875756
    60 TABLET in 1 BOTTLE (68788-7575-6)
  • ndc11
    6878875757
    25 TABLET in 1 BOTTLE (68788-7575-7)
  • ndc11
    6878875758
    35 TABLET in 1 BOTTLE (68788-7575-8)

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": "68788-7575_9248c792-3664-4f8e-9d1d-3c4344deb9fc",
  "productndc": "68788-7575",
  "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

Other records sharing ATC code J05AB01.

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