Lamivudine Tablet, Film Coated
NDC Package 64380-710-03

11-digit billing NDC: 64380071003 · Billing unit: EA · 60 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lamivudine tablets is lamivudine 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 tablet, film coated delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-710 and is authorized under FDA application ANDA090457.

Identification & Billing

NDC Package Code
64380-710-03
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
64380-710
11-Digit Billing Format
64380071003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamivudine
Non-Proprietary Name
Lamivudine
Substance Name
Lamivudine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAMIVUDINE 150 mg/1
Pharmacologic Class
Usage Information
Lamivudine 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
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090457
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-19-2018
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 64380-710-03 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Lamivudine, a human prescription drug labeled by Strides Pharma Science Limited. This tablet, film coated 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 Strides Pharma Science Limited on October 19, 2018. The current certification is valid through December 31, 2027.

How is this Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380071003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
64380-710-03
11-Digit CMS (5-4-2)
64380-0710-03

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