Infuvite Pediatric

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5464356470
1 KIT in 1 CARTON (54643-5647-0) * 40 mL in 1 VIAL (54643-5653-0) * 10 mL in 1 VIAL (54643-5655-0)

Annotations

Orange Book

N021265

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "14c7bfc5-07e8-400f-b8ff-5e4794dd2805": {
      "match": "brand_token",
      "title": "INFUVITE ADULT (MULTIPLE VITAMINS INJECTION) KIT [SANDOZ INC]",
      "spl_version": "18",
      "published_date": "2024-12-06"
    }
  },
  "productid": "54643-5647_7af6954f-c80e-4673-b47d-457de4288bec",
  "productndc": "54643-5647",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Infuvite Pediatric",
  "active_ingred_unit": null,
  "application_number": "NDA021265",
  "marketing_category": "NDA",
  "nonproprietary_name": "multiple vitamins injection",
  "start_marketing_date": "20010221",
  "active_numerator_strength": null
}

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