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United States · US · US:54643-9023_447b597f-d7fe-4489-b755-9929b40032f4

Pediatric Infuvite Multiple Vitamins

Orange BookUNIISPLATC A11GA

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA11GA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5464390231
    10 VIAL in 1 CARTON (54643-9023-1) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
9E8X80D2L0
.ALPHA.-TOCOPHEROL ACETATE
RxCUI 1046243
Orange Book
N021265
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9E8X80D2L0",
    "rxcui": "1046243",
    "inchikey": null,
    "display_name": ".ALPHA.-TOCOPHEROL ACETATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5769ce2c-d2e1-4069-92cc-e38bee668daf": {
      "match": "brand_token",
      "title": "PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]",
      "spl_version": "9",
      "published_date": "2025-12-19"
    }
  },
  "productid": "54643-9023_447b597f-d7fe-4489-b755-9929b40032f4",
  "productndc": "54643-9023",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021265",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL",
        "product_no": "001",
        "approval_date": "Feb 21, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL",
        "product_no": "002",
        "approval_date": "Jan 29, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE",
  "proprietary_name": "Pediatric Infuvite Multiple Vitamins",
  "active_ingred_unit": "[iU]/5mL; mg/5mL; ug/5mL; [iU]/5mL; ug/5mL; mg/5mL; ug/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL",
  "application_number": "NDA021265",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin",
  "start_marketing_date": "20161223",
  "active_numerator_strength": "7; 80; 20; 400; 1; 5; 140; 17; .2; 1; 1.4; 1.2; 2300"
}

Related drugs

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