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United States · US · US:76310-024_6792504c-7fa0-4179-9c76-1f6a2ced2832

Foscavir

Orange BookUNIISPLATC J05AD01

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

Identification

ManufacturerClinigen Limited
CountryUS (United States)
ATC codeJ05AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7631002425
    10 CARTON in 1 CARTON (76310-024-25) / 1 BOTTLE in 1 CARTON (76310-024-15) / 250 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
964YS0OOG1
FOSCARNET SODIUM
RxCUI 57529
Orange Book
N020068
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "964YS0OOG1",
    "rxcui": "57529",
    "inchikey": "ILRVASBWNRYBFD-UHFFFAOYSA-K",
    "display_name": "FOSCARNET SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "90e3da4e-3b1f-428b-99ca-e4bed1c80028": {
      "match": "brand_token",
      "title": "FOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN LIMITED]",
      "spl_version": "16",
      "published_date": "2025-12-12"
    }
  },
  "productid": "76310-024_6792504c-7fa0-4179-9c76-1f6a2ced2832",
  "productndc": "76310-024",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020068",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "6GM/250ML (24MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 27, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12GM/500ML (24MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 27, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSCARNET SODIUM",
  "proprietary_name": "Foscavir",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020068",
  "marketing_category": "NDA",
  "nonproprietary_name": "foscarnet sodium",
  "start_marketing_date": "20120709",
  "active_numerator_strength": "24"
}

Related drugs

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