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  5. NDC Package Code: 69238-1574-1 Sildenafil

NDC Package 69238-1574-1 Sildenafil

Powder, For Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
69238-1574-1
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 112 mL in 1 BOTTLE, GLASS
Product Code:
69238-1574
Proprietary Name:
Sildenafil
Non-Proprietary Name:
Sildenafil
Substance Name:
Sildenafil
Usage Information:
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil for oral suspension was added to background epoprostenol therapy [see Clinical Studies (14)]. Studies establishing effectiveness were short-term (12 weeks to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
11-Digit NDC Billing Format:
69238157401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1307427 - sildenafil 10 MG in 1 mL Oral Suspension
  • RxCUI: 1307427 - sildenafil 10 MG/ML Oral Suspension
  • RxCUI: 1307427 - sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral Suspension
  • RxCUI: 1307427 - sildenafil 10 MG per 1 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Ny Llc
    Dosage Form:
    Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SILDENAFIL 10 mg/mL
    • Pharmacologic Class(es):
  • Phosphodiesterase 5 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Phosphodiesterase 5 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211092
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-06-2019
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 69238-1574-1?

    The NDC Packaged Code 69238-1574-1 is assigned to a package of 1 bottle, glass in 1 carton / 112 ml in 1 bottle, glass of Sildenafil, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is powder, for suspension and is administered via oral form.

    Is NDC 69238-1574 included in the NDC Directory?

    Yes, Sildenafil with product code 69238-1574 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on December 06, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 69238-1574-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 69238-1574-1?

    The 11-digit format is 69238157401. 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 5-4-1 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
    5-4-169238-1574-15-4-269238-1574-01