Nalbuphine Hydrochloride Injection, Solution
NDC Package 0409-1463-49

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    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, solution delivery system. Marketed by Hospira, Inc., this product is identified by NDC 0409-1463 and is authorized under FDA application ANDA070914.

Identification & Billing

NDC Package Code
0409-1463-49
Package Description
10 AMPULE in 1 TRAY / 1 mL in 1 AMPULE (0409-1463-69)
Product Code
0409-1463
11-Digit Billing Format
00409146349
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, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
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.
  • 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)
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
Hospira, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA070914
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0409-1463). Click a package code to view its specific billing and regulatory data.

0409-1463-01
10 AMPULE in 1 TRAY / 1 mL in 1 AMPULE (0409-1463-71)

* 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 0409-1463-49 identifies a specific commercial package of 10 ampule in 1 tray / 1 ml in 1 ampule (0409-1463-69) of Nalbuphine Hydrochloride, a human prescription drug labeled by Hospira, Inc.. This injection, solution 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 Hospira, Inc. on June 27, 2008. The current certification is valid through December 31, 2027.

How is this Hospira, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409146349. 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 (4-4-2)
0409-1463-49
11-Digit CMS (5-4-2)
00409-1463-49

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