Nifedipine Tablet, Extended Release
NDC Package 72789-486-01

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

Package Information

Nifedipine tablets is a medication used to prevent certain types of chest pain (angina). This formulation utilizes a tablet, extended release delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-486 and is authorized under FDA application ANDA216067.

Identification & Billing

NDC Package Code
72789-486-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
72789-486
11-Digit Billing Format
72789048601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1812015 - NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1812015 - Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet
  • RxCUI: 1812015 - nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Nifedipine
Non-Proprietary Name
Nifedipine
Substance Name
Nifedipine
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NIFEDIPINE 90 mg/1
Pharmacologic Class
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
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216067
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72789-486-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle, plastic of Nifedipine, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, extended release is formulated for oral use and contains nifedipine 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 Pd-rx Pharmaceuticals, Inc. on March 30, 2022. The current certification is valid through December 31, 2027.

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 Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789048601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
72789-486-01
11-Digit CMS (5-4-2)
72789-0486-01

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