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United States · US · US:0143-9658_dbf69540-34d6-423d-a06a-e5eddfd40ae3

Acyclovir

Orange BookUNIISPLATC J05AB01

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

Identification

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

Packs · 1

  • ndc11
    0143965810
    10 VIAL, SINGLE-DOSE in 1 BOX (0143-9658-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9658-01)

Annotations

UNII (FDA Substance ID)
927L42J563
ACYCLOVIR SODIUM
RxCUI 81944
Orange Book
A205771
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "927L42J563",
    "rxcui": "81944",
    "inchikey": "RMLUKZWYIKEASN-UHFFFAOYSA-M",
    "display_name": "ACYCLOVIR SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "0143-9658_dbf69540-34d6-423d-a06a-e5eddfd40ae3",
  "productndc": "0143-9658",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "205771",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Feb 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Feb 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACYCLOVIR SODIUM",
  "proprietary_name": "Acyclovir",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA205771",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acyclovir",
  "start_marketing_date": "20160229",
  "active_numerator_strength": "1"
}

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