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United States · US · US:68788-8724_9ffeaf80-77c0-43c2-9acb-469d537c184a

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

ManufacturerPreferred Pharmaceuticals Inc
CountryUS (United States)
ATC codeJ05AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6878887241
    100 TABLET in 1 BOTTLE (68788-8724-1)
  • ndc11
    6878887242
    21 TABLET in 1 BOTTLE (68788-8724-2)
  • ndc11
    6878887243
    30 TABLET in 1 BOTTLE (68788-8724-3)
  • ndc11
    6878887244
    40 TABLET in 1 BOTTLE (68788-8724-4)
  • ndc11
    6878887245
    50 TABLET in 1 BOTTLE (68788-8724-5)
  • ndc11
    6878887248
    35 TABLET in 1 BOTTLE (68788-8724-8)

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": "68788-8724_9ffeaf80-77c0-43c2-9acb-469d537c184a",
  "productndc": "68788-8724",
  "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": "20240816",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J05AB01.

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