Pralatrexate Injection
NDC Package 43598-342-11

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

Package Information

Pralatrexate injection is pralatrexate is used to treat a certain type of cancer (peripheral T-Cell lymphoma-PTCL). This formulation utilizes a injection delivery system. Marketed by Dr.reddy's Laboratories Inc.,, this product is identified by NDC 43598-342 and is authorized under FDA application ANDA206183.

Identification & Billing

NDC Package Code
43598-342-11
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
43598-342
11-Digit Billing Format
43598034211
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pralatrexate
Non-Proprietary Name
Pralatrexate
Substance Name
Pralatrexate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PRALATREXATE 20 mg/mL
Pharmacologic Class
Folate Analog Metabolic Inhibitor - [EPC] (Established Pharmacologic Class)
Usage Information
Pralatrexate is used to treat a certain type of cancer (peripheral T-Cell lymphoma-PTCL). Pralatrexate works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Dr.reddy's Laboratories Inc.,
Product Type
Human Prescription Drug
FDA Application #
ANDA206183
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2026
Listing Expiration
12-31-2027
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 43598-342-11 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Pralatrexate, a human prescription drug labeled by Dr.reddy's Laboratories Inc.,. This injection is formulated for intravenous use and contains pralatrexate 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 04, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Pralatrexate is used to treat a certain type of cancer (peripheral T-Cell lymphoma-PTCL). Pralatrexate works by slowing or stopping the growth of cancer cells.

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: 43598034211. 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)
43598-342-11
11-Digit CMS (5-4-2)
43598-0342-11

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