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United States · US · US:82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    8280400506
    6 TABLET in 1 BOTTLE (82804-005-06)
  • ndc11
    8280400515
    15 TABLET in 1 BOTTLE (82804-005-15)
  • ndc11
    8280400520
    20 TABLET in 1 BOTTLE (82804-005-20)
  • ndc11
    8280400521
    21 TABLET in 1 BOTTLE (82804-005-21)
  • ndc11
    8280400530
    30 TABLET in 1 BOTTLE (82804-005-30)
  • ndc11
    8280400535
    35 TABLET in 1 BOTTLE (82804-005-35)
  • ndc11
    8280400560
    60 TABLET in 1 BOTTLE (82804-005-60)
  • ndc11
    8280400590
    90 TABLET in 1 BOTTLE (82804-005-90)

Annotations

UNII (FDA Substance ID)
X4HES1O11F
ACYCLOVIR
RxCUI 281
Orange Book
A210401
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": "82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c",
  "productndc": "82804-005",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210401",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Mar 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Mar 7, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210401",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20230620",
  "active_numerator_strength": "400"
}

Related drugs

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