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  5. NDC Package Code: 53489-369-10 Felodipine

NDC Package 53489-369-10 Felodipine

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53489-369-10
Package Description:
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
53489-369
Proprietary Name:
Felodipine
Non-Proprietary Name:
Felodipine
Substance Name:
Felodipine
Usage Information:
Felodipine is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Felodipine is known as a calcium channel blocker. By blocking calcium, this medication relaxes and widens blood vessels so blood can flow more easily.
11-Digit NDC Billing Format:
53489036910
NDC to RxNorm Crosswalk:
  • RxCUI: 402695 - felodipine 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 402695 - 24 HR felodipine 10 MG Extended Release Oral Tablet
  • RxCUI: 402695 - felodipine 10 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 402696 - felodipine 5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 402696 - 24 HR felodipine 5 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FELODIPINE 5 mg/1
    • Pharmacologic Class(es):
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Dihydropyridines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA075896
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-02-2004
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53489-369-01100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    53489-369-03250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    53489-369-05500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    53489-369-0730 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    53489-369-9090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53489-369-10?

    The NDC Packaged Code 53489-369-10 is assigned to a package of 1000 tablet, film coated, extended release in 1 bottle, plastic of Felodipine, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 53489-369 included in the NDC Directory?

    Yes, Felodipine with product code 53489-369 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on November 02, 2004 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53489-369-10?

    The 11-digit format is 53489036910. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253489-369-105-4-253489-0369-10