Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate Tablet
NDC Package 0904-7010-06

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

Package Information

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate 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 Major Pharmaceuticals, this product is identified by NDC 0904-7010 and is authorized under FDA application ANDA203326.

Identification & Billing

NDC Package Code
0904-7010-06
Package Description
50 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
0904-7010
11-Digit Billing Format
00904701006
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 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 Hydrochloride And Naloxone Hydrochloride Dihydrate
Non-Proprietary Name
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Substance Name
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
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 to include counseling and psychosocial support.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA203326
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2014
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0574
Source: PDAC
BUPRENORPHINE/NALOXONE, ORAL, GREATER THAN 6 MG, BUT LESS THAN OR EQUAL TO 10 MG BUPRENORPHINE
HCPCS Dosage 8 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0904-7010-06 identifies a specific commercial package of 50 blister pack in 1 carton / 1 tablet in 1 blister pack of Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate, a human prescription drug labeled by Major Pharmaceuticals. This tablet is formulated for sublingual use and contains buprenorphine hydrochloride; naloxone hydrochloride dihydrate 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 Major Pharmaceuticals on June 27, 2014. The current certification is valid through December 31, 2027.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904701006. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 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)
0904-7010-06
11-Digit CMS (5-4-2)
00904-7010-06

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