Nebivolol Tablet
NDC Package 71209-059-11

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

Nebivolol tablets is  is contraindicated in the following conditions: Severe bradycardiaHeart block greater than first degree Patients with cardiogenic shock Decompensated cardiac failureSick sinus syndrome (unless a permanent pacemaker is in place) Patients with severe hepatic impairment (Child-Pugh >B)Patients who are hypersensitive to any component of this product. This formulation utilizes a tablet delivery system. Marketed by Cadila Pharmaceuticals Limited, this product is identified by NDC 71209-059 and is authorized under FDA application ANDA208717.

Identification & Billing

NDC Package Code
71209-059-11
Package Description
1000 TABLET in 1 BOTTLE
Product Code
71209-059
11-Digit Billing Format
71209005911
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nebivolol
Non-Proprietary Name
Nebivolol
Substance Name
Nebivolol Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NEBIVOLOL HYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
Nebivolol Tablets is contraindicated in the following conditions: Severe bradycardiaHeart block greater than first degree Patients with cardiogenic shock Decompensated cardiac failureSick sinus syndrome (unless a permanent pacemaker is in place) Patients with severe hepatic impairment (Child-Pugh >B)Patients who are hypersensitive to any component of this product.

Regulatory & Marketing

Labeler Name
Cadila Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA208717
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71209-059). Click a package code to view its specific billing and regulatory data.

71209-059-01
30 TABLET in 1 BOTTLE
71209-059-04
90 TABLET in 1 BOTTLE
71209-059-05
100 TABLET in 1 BOTTLE

* 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 71209-059-11 identifies a specific commercial package of 1000 tablet in 1 bottle of Nebivolol, a human prescription drug labeled by Cadila Pharmaceuticals Limited. This tablet is formulated for oral use and contains nebivolol 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 Cadila Pharmaceuticals Limited on December 29, 2017. The current certification is valid through December 31, 2026.

How is this Cadila Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71209005911. 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)
71209-059-11
11-Digit CMS (5-4-2)
71209-0059-11

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