Thiamine Hydrochloride Injection, Solution
NDC Package 43598-050-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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 Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-050 and is authorized under FDA application ANDA080571.

Identification & Billing

NDC Package Code
43598-050-25
Package Description
25 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE (43598-050-11)
Product Code
43598-050
11-Digit Billing Format
43598005025
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
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 100 mg/mL
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
Dr. Reddy's Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA080571
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2023
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3411
Source: ASP
Thiamine hcl 100 mg
HCPCS Dosage 100 MG
Units / Pkg 50

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 43598-050-25 identifies a specific commercial package of 25 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose (43598-050-11) of Thiamine Hydrochloride, a human prescription drug labeled by Dr. Reddy's Laboratories Inc.. 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 Dr. Reddy's Laboratories Inc. on March 31, 2023. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598005025. 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 (5-3-2)
43598-050-25
11-Digit CMS (5-4-2)
43598-0050-25

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