Nalbuphine Hydrochloride Injection
NDC Package 70069-671-10

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

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 Somerset Therapeutics, Llc, this product is identified by NDC 70069-671 and is authorized under FDA application ANDA216050.

Identification & Billing

NDC Package Code
70069-671-10
Package Description
10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE (70069-671-01)
Product Code
70069-671
11-Digit Billing Format
70069067110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216050
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2024
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.

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.

J2300
Source: PDAC
INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10 MG
HCPCS Dosage 10 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 70069-671-10 identifies a specific commercial package of 10 ampule in 1 carton / 1 ml in 1 ampule (70069-671-01) of Nalbuphine Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, 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 Somerset Therapeutics, Llc on September 25, 2024. The current certification is valid through December 31, 2026.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069067110. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
70069-671-10
11-Digit CMS (5-4-2)
70069-0671-10

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