Buprenorphine Hydrochloride Tablet
NDC Package 0121-1019-30

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

Package Information

Buprenorphine Hydrochloride tablets is buprenorphine sublingual tablets is indicated for the treatment of opioid dependence and is preferred for induction. 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 0121-1019 and is authorized under FDA application ANDA090622.

Identification & Billing

NDC Package Code
0121-1019-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
0121-1019
11-Digit Billing Format
00121101930
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
Buprenorphine Hydrochloride
Non-Proprietary Name
Buprenorphine Hydrochloride
Substance Name
Buprenorphine 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)
BUPRENORPHINE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Buprenorphine sublingual tablets is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include 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 #
ANDA090622
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2023
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 0121-1019-30 identifies a specific commercial package of 30 tablet in 1 bottle of Buprenorphine Hydrochloride, 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 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 October 12, 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: 00121101930. 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)
0121-1019-30
11-Digit CMS (5-4-2)
00121-1019-30

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