Nifedipine
NDC Package 0378-3475-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Nifedipine is a medication used to prevent certain types of chest pain (angina). Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3475 and is authorized under FDA application NDA019684.

Identification & Billing

NDC Package Code
0378-3475-30
Package Description
300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
11-Digit Billing Format
00378347530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
300 EA

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
Mylan Pharmaceuticals Inc.
FDA Application #
NDA019684
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-06-1989
End Marketing Date
08-31-2014
Listing Expiration
08-31-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0378-3475). Click a package code to view its specific billing and regulatory data.

100 TABLET, FILM COATED, EXTENDED RELEASE 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 0378-3475-30 identifies a specific commercial package of 300 tablet, film coated, extended release in 1 bottle of Nifedipine, labeled by Mylan Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 300 billable units per package. 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 Mylan Pharmaceuticals Inc. on September 06, 1989. The current certification is valid through August 31, 2014.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378347530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 300 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 (4-4-2)
0378-3475-30
11-Digit CMS (5-4-2)
00378-3475-30

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