Lamivudine Solution
NDC Package 57237-274-24

11-digit billing NDC: 57237027424 · Billing unit: ML · 240 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lamivudine solution is lamivudine oral solution is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This formulation utilizes a solution delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-274 and is authorized under FDA application ANDA077695.

Identification & Billing

NDC Package Code
57237-274-24
Package Description
240 mL in 1 BOTTLE
Product Code
57237-274
11-Digit Billing Format
57237027424
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamivudine
Non-Proprietary Name
Lamivudine
Substance Name
Lamivudine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAMIVUDINE 10 mg/mL
Pharmacologic Class
Usage Information
Lamivudine oral solution is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077695
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2016
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 57237-274-24 identifies a specific commercial package of 240 ml in 1 bottle of Lamivudine, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This solution is formulated for oral use and contains lamivudine 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 Rising Pharma Holdings, Inc. on November 21, 2016. The current certification is valid through December 31, 2027.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237027424. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 total billable units per package. 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)
57237-274-24
11-Digit CMS (5-4-2)
57237-0274-24

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