Infuvite Pediatric Kit
NDC Package 54643-5646-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Infuvite Pediatric (multiple vitamins injection) kits is iNFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. This formulation utilizes a kit delivery system. Marketed by Sandoz Inc, this product is identified by NDC 54643-5646 and is authorized under FDA application NDA021265.

Identification & Billing

NDC Package Code
54643-5646-1
Package Description
1 KIT in 1 CARTON * 4 mL in 1 VIAL (54643-5648-1) * 1 mL in 1 VIAL (54643-5651-1)
Product Code
54643-5646
11-Digit Billing Format
54643564601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1305217 - alpha-tocopherol acetate 1.4 UNT/ML / ascorbic acid 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folic acid 0.028 MG/ML / niacinamide 3.4 MG/ML / pyridoxine hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / thiamine hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution
  • RxCUI: 1305217 - alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution
  • RxCUI: 1305217 - alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution
  • RxCUI: 1305217 - alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution
  • RxCUI: 1305217 - alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Infuvite Pediatric
Non-Proprietary Name
Multiple Vitamins Injection
Dosage Form
Kit - A packaged collection of related material.
Usage Information
INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA021265
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-21-2001
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54643-5646-1 identifies a specific commercial package of 1 kit in 1 carton * 4 ml in 1 vial (54643-5648-1) * 1 ml in 1 vial (54643-5651-1) of Infuvite Pediatric, a human prescription drug labeled by Sandoz Inc. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sandoz Inc on February 21, 2001. The current certification is valid through December 31, 2026.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54643564601. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54643-5646-1
11-Digit CMS (5-4-2)
54643-5646-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.