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United States · US · US:63187-574_4a7f6547-dac8-4cf9-9834-ae6815f154b5

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
    6318757406
    6 TABLET in 1 BOTTLE (63187-574-06)
  • ndc11
    6318757420
    20 TABLET in 1 BOTTLE (63187-574-20)
  • ndc11
    6318757425
    25 TABLET in 1 BOTTLE (63187-574-25)
  • ndc11
    6318757430
    30 TABLET in 1 BOTTLE (63187-574-30)
  • ndc11
    6318757435
    35 TABLET in 1 BOTTLE (63187-574-35)
  • ndc11
    6318757450
    50 TABLET in 1 BOTTLE (63187-574-50)
  • ndc11
    6318757460
    60 TABLET in 1 BOTTLE (63187-574-60)
  • ndc11
    6318757490
    90 TABLET in 1 BOTTLE (63187-574-90)

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": "63187-574_4a7f6547-dac8-4cf9-9834-ae6815f154b5",
  "productndc": "63187-574",
  "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": "800"
}

Related drugs

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