acyclovir

Orange BookUNIISPLATC J05AB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6626739915
15 TABLET in 1 BOTTLE (66267-399-15)
ndc11
6626739921
21 TABLET in 1 BOTTLE (66267-399-21)
ndc11
6626739925
25 TABLET in 1 BOTTLE (66267-399-25)
ndc11
6626739930
30 TABLET in 1 BOTTLE (66267-399-30)
ndc11
6626739935
35 TABLET in 1 BOTTLE (66267-399-35)
ndc11
6626739950
50 TABLET in 1 BOTTLE (66267-399-50)

Annotations

UNII (FDA Substance ID)

X4HES1O11F

ACYCLOVIR

RxCUI 281

Orange Book

A204314

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": "66267-399_1fa6dc86-6637-c362-e063-6394a90a4c03",
  "productndc": "66267-399",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204314",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Aug 19, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "acyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acyclovir",
  "start_marketing_date": "20140910",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code J05AB01.

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