Nifedipine
NDC Package 54458-950-10

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 inactivated by the FDA.

Nifedipine is a medication used to prevent certain types of chest pain (angina). Marketed by International Laboratories, Llc, this product is identified by NDC 54458-950 and is authorized under FDA application ANDA077127.

Identification & Billing

NDC Package Code
54458-950-10
Package Description
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
54458-950
11-Digit Billing Format
54458095010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1812011 - NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1812011 - Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet
  • RxCUI: 1812011 - nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet
  • RxCUI: 1812013 - NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1812013 - Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Nifedipine
Dosage Form
-
Usage Information
This medication is used to prevent certain types of chest pain (angina). It may allow you to exercise more and decrease the frequency of angina attacks. Nifedipine belongs to a class of medications known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. This medication must be taken regularly to be effective. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor. Consult your doctor or pharmacist for details. Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other possibly safer forms of nifedipine (such as the long-acting tablets).

Regulatory & Marketing

Labeler Name
International Laboratories, Llc
FDA Application #
ANDA077127
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-2009
Listing Expiration
12-31-2018
Exclude Flag
I
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 54458-950-10 identifies a specific commercial package of 30 tablet, extended release in 1 blister pack of Nifedipine, labeled by International Laboratories, Llc. 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 International Laboratories, Llc on August 21, 2009. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

This medication is used to prevent certain types of chest pain (angina). It may allow you to exercise more and decrease the frequency of angina attacks. Nifedipine belongs to a class of medications known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. This medication must be taken regularly to be effective. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor. Consult your doctor or pharmacist for details. Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other possibly safer forms of nifedipine (such as the long-acting tablets).

How is this International Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54458095010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
54458-950-10
11-Digit CMS (5-4-2)
54458-0950-10

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