Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeJ05AB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6807124471
21 TABLET in 1 BOTTLE, PLASTIC (68071-2447-1)
ndc11
6807124473
30 TABLET in 1 BOTTLE, PLASTIC (68071-2447-3)
ndc11
6807124474
40 TABLET in 1 BOTTLE, PLASTIC (68071-2447-4)
ndc11
6807124475
25 TABLET in 1 BOTTLE, PLASTIC (68071-2447-5)
ndc11
6807124476
60 TABLET in 1 BOTTLE, PLASTIC (68071-2447-6)
ndc11
6807124478
15 TABLET in 1 BOTTLE, PLASTIC (68071-2447-8)

Annotations

UNII (FDA Substance ID)

X4HES1O11F

ACYCLOVIR

RxCUI 281

Orange Book

A075382

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": "68071-2447_2048c55f-8391-e891-e063-6394a90a06fb",
  "productndc": "68071-2447",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075382",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Apr 30, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Apr 30, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075382",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20091022",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J05AB01.

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