NDC Package 0378-1659-93 Sildenafil

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

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:
0378-1659-93
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Sildenafil
Non-Proprietary Name:
Sildenafil
Substance Name:
Sildenafil Citrate
Usage Information:
Sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. This medication is not recommended for use in children. Discuss the risks and benefits of this medication with the doctor.
11-Digit NDC Billing Format:
00378165993
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 312950 - sildenafil citrate 50 MG Oral Tablet
  • RxCUI: 312950 - sildenafil 50 MG Oral Tablet
  • RxCUI: 312950 - sildenafil 50 MG (as sildenafil citrate) Oral Tablet
  • RxCUI: 314228 - sildenafil citrate 25 MG Oral Tablet
  • RxCUI: 314228 - sildenafil 25 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Tablet, Film Coated - 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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA201171
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-04-2019
    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
    0378-1659-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    0378-1659-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-1659-93?

    The NDC Packaged Code 0378-1659-93 is assigned to a package of 30 tablet, film coated in 1 bottle, plastic of Sildenafil, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0378-1659 included in the NDC Directory?

    Yes, Sildenafil with product code 0378-1659 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on April 04, 2019 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 NDC billing unit for package 0378-1659-93?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 0378-1659-93?

    The 11-digit format is 00378165993. 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 4-4-2 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
    4-4-20378-1659-935-4-200378-1659-93