Rilpivirine Tablet, Film Coated
NDC Package 70069-848-30

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

Package Information

Rilpivirine tablets are 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 tablets or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3)].Table 2: Drugs That are Contraindicated with Rilpivirine Tablets 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Somerset Therapeutics, Llc, this product is identified by NDC 70069-848 and is authorized under FDA application ANDA218798.

Identification & Billing

NDC Package Code
70069-848-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
70069-848
11-Digit Billing Format
70069084830
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

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 tablets are 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 tablets or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3)].Table 2: Drugs That are Contraindicated with Rilpivirine Tablets 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
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-30-2026
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 70069-848-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Rilpivirine, a human prescription drug labeled by Somerset Therapeutics, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Somerset Therapeutics, Llc on January 30, 2026. The current certification is valid through December 31, 2027.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069084830. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
70069-848-30
11-Digit CMS (5-4-2)
70069-0848-30

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