Thiamine Hydrochloride Injection, Solution
NDC Package 68083-567-25

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

Package 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. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-567 and is authorized under FDA application ANDA217800.

Identification & Billing

NDC Package Code
68083-567-25
Package Description
25 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code
68083-567
11-Digit Billing Format
68083056725
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
Non-Proprietary Name
Thiamine Hydrochloride
Substance Name
Thiamine Hydrochloride
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
THIAMINE HYDROCHLORIDE 200 mg/2mL
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217800
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-24-2025
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 68083-567-25 identifies a specific commercial package of 25 vial in 1 carton / 2 ml in 1 vial of Thiamine Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intramuscular; intravenous use and contains thiamine hydrochloride 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 Gland Pharma Limited on February 24, 2025. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083056725. 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 (5-3-2)
68083-567-25
11-Digit CMS (5-4-2)
68083-0567-25

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