Nalbuphine Hydrochloride
NDC Package 0555-1122-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nalbuphine Hydrochloride is a . Marketed by Barr Laboratories, Inc., this product is identified by NDC 0555-1122 and is authorized under FDA application ANDA070916.

Identification & Billing

NDC Package Code
0555-1122-05
Package Description
10 AMPULE in 1 BOX / 1 mL in 1 AMPULE
Product Code
0555-1122
11-Digit Billing Format
00555112205

Clinical Specifications

Proprietary Name
Nalbuphine Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Barr Laboratories, Inc.
FDA Application #
ANDA070916
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-19-1998
End Marketing Date
02-28-2011
Listing Expiration
02-28-2011
Exclude Flag
D
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 0555-1122-05 identifies a specific commercial package of 10 ampule in 1 box / 1 ml in 1 ampule of Nalbuphine Hydrochloride, labeled by Barr Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Barr Laboratories, Inc. on May 19, 1998. The current certification is valid through February 28, 2011.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00555112205. 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)
0555-1122-05
11-Digit CMS (5-4-2)
00555-1122-05

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