Rilpivirine Tablet, Film Coated
NDC Package 42385-999-31

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

Package Information

Rilpivirine tablets is rilpivirine is contraindicated for coadministration with the drugs in Table 2 for which significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3)].                              Table 2: Drugs That are Contraindicated with Rilpivirine   Drug Class  Contraindicated Drugs in Class  Clinical Comment  Anticonvulsants  Carbamazepine Oxcarbazepine Phenobarbital Phenytoin  Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme induction, which may result in loss of virologic response.  Antimycobacterials  Rifampin  Rifapentine  Glucocorticoid (systemic)  Dexamethasone (more than a single- dose treatment)  Herbal Products  St. This formulation utilizes a tablet, film coated delivery system. Marketed by Laurus Labs Limited, this product is identified by NDC 42385-999 and is authorized under FDA application ANDA219788.

Identification & Billing

NDC Package Code
42385-999-31
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
42385-999
11-Digit Billing Format
42385099931

Clinical Specifications

Proprietary Name
Rilpivirine
Non-Proprietary Name
Rilpivirine
Substance Name
Rilpivirine Hydrochloride
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)
RILPIVIRINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Rilpivirine is contraindicated for coadministration with the drugs in Table 2 for which significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3)].                              Table 2: Drugs That are Contraindicated with Rilpivirine   Drug Class  Contraindicated Drugs in Class  Clinical Comment  Anticonvulsants  Carbamazepine Oxcarbazepine Phenobarbital Phenytoin  Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme induction, which may result in loss of virologic response.  Antimycobacterials  Rifampin  Rifapentine  Glucocorticoid (systemic)  Dexamethasone (more than a single- dose treatment)  Herbal Products  St. John’s wort (Hypericum perforatum)  Proton Pump Inhibitors  e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole  Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response.                                                                

Regulatory & Marketing

Labeler Name
Laurus Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA219788
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-10-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42385-999). Click a package code to view its specific billing and regulatory data.

42385-999-30
30 TABLET, FILM COATED in 1 BOTTLE

* 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 42385-999-31 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Rilpivirine, a human prescription drug labeled by Laurus Labs Limited. This tablet, film coated is formulated for oral use and contains rilpivirine 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 Laurus Labs Limited on July 10, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42385099931. 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)
42385-999-31
11-Digit CMS (5-4-2)
42385-0999-31

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