Buprenorphine And Naloxone Tablet
NDC Package 0121-1018-30

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

Package Information

Buprenorphine And Naloxone (buprenorphine hydrochloride and naloxone hydrochloride) tablets is buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. This formulation utilizes a tablet delivery system. Marketed by Pai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma, this product is identified by NDC 0121-1018 and is authorized under FDA application ANDA204431.

Identification & Billing

NDC Package Code
0121-1018-30
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
0121-1018
11-Digit Billing Format
00121101830
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 351266 - buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet
  • RxCUI: 351266 - buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet
  • RxCUI: 351266 - buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet
  • RxCUI: 351267 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet
  • RxCUI: 351267 - buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet

Clinical Specifications

Proprietary Name
Buprenorphine And Naloxone
Non-Proprietary Name
Buprenorphine Hydrochloride And Naloxone Hydrochloride
Substance Name
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA204431
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-05-2023
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 0121-1018-30 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Buprenorphine And Naloxone, a human prescription drug labeled by Pai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma. This tablet is formulated for sublingual use and contains buprenorphine hydrochloride; naloxone 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 Pai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma on September 05, 2023. The current certification is valid through December 31, 2027.

How is this Pai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121101830. 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 (4-4-2)
0121-1018-30
11-Digit CMS (5-4-2)
00121-1018-30

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