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  5. NDC Package Code: 68083-567-25 Thiamine Hydrochloride

NDC Package 68083-567-25 Thiamine Hydrochloride

Injection, Solution Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68083-567-25
Package Description:
25 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code:
68083-567
Proprietary Name:
Thiamine Hydrochloride
Non-Proprietary Name:
Thiamine Hydrochloride
Substance Name:
Thiamine Hydrochloride
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.
11-Digit NDC Billing Format:
68083056725
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Gland Pharma Limited
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
THIAMINE HYDROCHLORIDE 200 mg/2mL
Sample Package:
No
FDA Application Number:
ANDA217800
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-24-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 68083-567-25?

The NDC Packaged Code 68083-567-25 is assigned to a package of 25 vial in 1 carton / 2 ml in 1 vial of Thiamine Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

Is NDC 68083-567 included in the NDC Directory?

Yes, Thiamine Hydrochloride with product code 68083-567 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on February 24, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68083-567-25?

The 11-digit format is 68083056725. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-268083-567-255-4-268083-0567-25