Nevirapine Tablet
NDC Package 42571-131-60

11-digit billing NDC: 42571013160
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Nevirapine tablets is nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)]. This formulation utilizes a tablet delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-131 and is authorized under FDA application ANDA203080.

Identification & Billing

NDC Package Code
42571-131-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
42571-131
11-Digit Billing Format
42571013160
RxNorm Crosswalk
RxCUI: 199422 - nevirapine 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Nevirapine
Non-Proprietary Name
Nevirapine
Substance Name
Nevirapine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NEVIRAPINE 200 mg/1
Pharmacologic Class
Usage Information
Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use:Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in:adult females with CD4 +cell counts greater than 250 cells/mm 3or adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] .

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203080
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42571-131). Click a package code to view its specific billing and regulatory data.

42571-131-29
6 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

* 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 42571-131-60 identifies a specific commercial package of 60 tablet in 1 bottle of Nevirapine, a human prescription drug labeled by Micro Labs Limited. This tablet is formulated for oral use and contains nevirapine 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 Micro Labs Limited on May 22, 2012. The current certification is valid through December 31, 2027.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571013160. 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)
42571-131-60
11-Digit CMS (5-4-2)
42571-0131-60

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