Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ05AB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6318725315
15 TABLET in 1 BOTTLE (63187-253-15)
ndc11
6318725321
21 TABLET in 1 BOTTLE (63187-253-21)
ndc11
6318725325
25 TABLET in 1 BOTTLE (63187-253-25)
ndc11
6318725330
30 TABLET in 1 BOTTLE (63187-253-30)
ndc11
6318725360
60 TABLET in 1 BOTTLE (63187-253-60)
ndc11
6318725390
90 TABLET in 1 BOTTLE (63187-253-90)

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": "63187-253_9f75bb4a-0416-403f-92bc-a3d0e50457c6",
  "productndc": "63187-253",
  "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": "400"
}

Related drugs

Other records sharing ATC code J05AB01.

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