🇺🇸
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
- ndc11546439023110 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"
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