Buprenorphine Hydrochloride Injection
NDC Package 68083-696-05

11-digit billing NDC: 68083069605
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Buprenorphine Hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use:Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including buprenorphine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. . This formulation utilizes a injection delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-696 and is authorized under FDA application ANDA221145.

Identification & Billing

NDC Package Code
68083-696-05
Package Description
5 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
68083-696
11-Digit Billing Format
68083069605

Clinical Specifications

Proprietary Name
Buprenorphine Hydrochloride
Non-Proprietary Name
Buprenorphine Hydrochloride
Substance Name
Buprenorphine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BUPRENORPHINE HYDROCHLORIDE .324 mg/mL
Pharmacologic Class
Usage Information
Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use:Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including buprenorphine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. 
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA221145
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-15-2026
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 68083-696-05 identifies a specific commercial package of 5 vial in 1 carton / 1 ml in 1 vial of Buprenorphine Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. This injection is formulated for intramuscular; intravenous 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 Gland Pharma Limited on October 15, 2026. The current certification is valid through December 31, 2027.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083069605. 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)
68083-696-05
11-Digit CMS (5-4-2)
68083-0696-05

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