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United States · US · US:65219-027_d6fd1a37-70e1-477a-afc9-4977a54c7b75

Ascorbic Acid

Orange BookUNIISPLATC G01AD03

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeG01AD03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6521902750
    25 VIAL, GLASS in 1 TRAY (65219-027-50) / 50 mL in 1 VIAL, GLASS (65219-027-05)
  • ndc11
    6521902755
    1 VIAL, GLASS in 1 CARTON (65219-027-55) / 50 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
PQ6CK8PD0R
ASCORBIC ACID
RxCUI 1151
Orange Book
A217131
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "PQ6CK8PD0R",
    "rxcui": "1151",
    "inchikey": "CIWBSHSKHKDKBQ-JLAZNSOCSA-N",
    "display_name": "ASCORBIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1606e29f-0e80-4069-b688-daab9cbff20a": {
      "match": "brand_token",
      "title": "ASCORBIC ACID INJECTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "1",
      "published_date": "2025-12-22"
    }
  },
  "productid": "65219-027_d6fd1a37-70e1-477a-afc9-4977a54c7b75",
  "productndc": "65219-027",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217131",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25,000MG/50ML (500MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 7, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASCORBIC ACID",
  "proprietary_name": "Ascorbic Acid",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217131",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ascorbic Acid",
  "start_marketing_date": "20251208",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code G01AD03.

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