Nalbuphine Hydrochloride Injection
NDC Package 71872-7331-1

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

Package Information

Nalbuphine Hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. This formulation utilizes a injection delivery system. Marketed by Medical Purchasing Solutions, Llc, this product is identified by NDC 71872-7331 and is authorized under FDA application ANDA216049.

Identification & Billing

NDC Package Code
71872-7331-1
Package Description
1 VIAL, MULTI-DOSE in 1 BAG / 10 mL in 1 VIAL, MULTI-DOSE
Product Code
71872-7331
11-Digit Billing Format
71872733101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nalbuphine Hydrochloride
Non-Proprietary Name
Nalbuphine Hydrochloride
Substance Name
Nalbuphine 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.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
NALBUPHINE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
Nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.Limitations of Use:Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia or are not expected to provide adequate analgesia.Nalbuphine hydrochloride injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Regulatory & Marketing

Labeler Name
Medical Purchasing Solutions, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216049
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-26-2024
Listing Expiration
12-31-2026
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 71872-7331-1 identifies a specific commercial package of 1 vial, multi-dose in 1 bag / 10 ml in 1 vial, multi-dose of Nalbuphine Hydrochloride, a human prescription drug labeled by Medical Purchasing Solutions, Llc. This injection is formulated for intramuscular; intravenous; subcutaneous use and contains nalbuphine 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 Medical Purchasing Solutions, Llc on September 26, 2024. The current certification is valid through December 31, 2026.

How is this Medical Purchasing Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71872733101. 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 (5-4-1)
71872-7331-1
11-Digit CMS (5-4-2)
71872-7331-01

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