Thiamine Hydrochloride
NDC Package 54868-2489-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Thiamine Hydrochloride is injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-2489 and is authorized under FDA application ANDA080556.

Identification & Billing

NDC Package Code
54868-2489-0
Package Description
1 VIAL, MULTI-DOSE in 1 CONTAINER / 2 mL in 1 VIAL, MULTI-DOSE
Product Code
54868-2489
11-Digit Billing Format
54868248900
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313324 - thiamine hydrochloride 100 MG/ML Injectable Solution
  • RxCUI: 313324 - vitamin B 1 100 MG/ML Injectable Solution
  • RxCUI: 313324 - vitamin B1 hydrochloride 100 MG/ML Injectable Solution
  • RxCUI: 313324 - vit-B1 hydrochloride 100 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Thiamine Hydrochloride
Dosage Form
-
Usage Information
Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA080556
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-18-2001
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-2489). Click a package code to view its specific billing and regulatory data.

54868-2489-1
25 VIAL, MULTI-DOSE in 1 BOX / 2 mL in 1 VIAL, MULTI-DOSE

* 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 54868-2489-0 identifies a specific commercial package of 1 vial, multi-dose in 1 container / 2 ml in 1 vial, multi-dose of Thiamine Hydrochloride, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on April 18, 2001. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868248900. 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)
54868-2489-0
11-Digit CMS (5-4-2)
54868-2489-00

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