Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ05AB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
4306392804
4 TABLET in 1 BOTTLE, PLASTIC (43063-928-04)
ndc11
4306392805
5 TABLET in 1 BOTTLE, PLASTIC (43063-928-05)
ndc11
4306392815
15 TABLET in 1 BOTTLE, PLASTIC (43063-928-15)
ndc11
4306392825
25 TABLET in 1 BOTTLE, PLASTIC (43063-928-25)
ndc11
4306392830
30 TABLET in 1 BOTTLE, PLASTIC (43063-928-30)
ndc11
4306392840
40 TABLET in 1 BOTTLE, PLASTIC (43063-928-40)
ndc11
4306392860
60 TABLET in 1 BOTTLE, PLASTIC (43063-928-60)

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": "43063-928_52cdc887-622c-564c-e063-6294a90ae005",
  "productndc": "43063-928",
  "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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