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United States · US · US:63629-1678_493fe3ca-2fb6-43a4-8bfd-44e53804d6f3

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    6362916780
    500 TABLET in 1 BOTTLE (63629-1678-0)
  • ndc11
    6362916781
    25 TABLET in 1 BOTTLE (63629-1678-1)
  • ndc11
    6362916782
    35 TABLET in 1 BOTTLE (63629-1678-2)
  • ndc11
    6362916783
    30 TABLET in 1 BOTTLE (63629-1678-3)
  • ndc11
    6362916784
    60 TABLET in 1 BOTTLE (63629-1678-4)
  • ndc11
    6362916785
    50 TABLET in 1 BOTTLE (63629-1678-5)
  • ndc11
    6362916786
    10 TABLET in 1 BOTTLE (63629-1678-6)
  • ndc11
    6362916787
    40 TABLET in 1 BOTTLE (63629-1678-7)
  • ndc11
    6362916788
    21 TABLET in 1 BOTTLE (63629-1678-8)
  • ndc11
    6362916789
    90 TABLET in 1 BOTTLE (63629-1678-9)

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A075382
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": "63629-1678_493fe3ca-2fb6-43a4-8bfd-44e53804d6f3",
  "productndc": "63629-1678",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075382",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Apr 30, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Apr 30, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075382",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20091022",
  "active_numerator_strength": "800"
}

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