acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeJ05AB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6584180201
100 TABLET in 1 BOTTLE (65841-802-01)
ndc11
6584180205
500 TABLET in 1 BOTTLE (65841-802-05)
ndc11
6584180206
30 TABLET in 1 BOTTLE (65841-802-06)
ndc11
6584180210
1000 TABLET in 1 BOTTLE (65841-802-10)
ndc11
6584180216
90 TABLET in 1 BOTTLE (65841-802-16)
ndc11
6584180230
10 BLISTER PACK in 1 CARTON (65841-802-30) / 10 TABLET in 1 BLISTER PACK

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": "65841-802_b401b7c4-9c22-470f-981e-da74bef39dc6",
  "productndc": "65841-802",
  "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": "400"
}

Related drugs

Other records sharing ATC code J05AB01.

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