NDC Package 0121-0810-16 Nystatin

Suspension 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:
0121-0810-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Nystatin
Non-Proprietary Name:
Nystatin
Substance Name:
Nystatin
Usage Information:
Nystatin is used to treat fungal skin infections. Nystatin is an antifungal that works by stopping the growth of fungus.
11-Digit NDC Billing Format:
00121081016
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 312055 - nystatin 100,000 UNT/mL Oral Suspension
  • RxCUI: 312055 - nystatin 100000 UNT/ML Oral Suspension
  • RxCUI: 312055 - nystatin 100,000 UNT/ML Oral Suspension
  • RxCUI: 312055 - nystatin 500,000 UNT per 5 ML Oral Suspension
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmaceutical Associates, Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA203621
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-01-2016
    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
    0121-0810-0260 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0121-0810-16?

    The NDC Packaged Code 0121-0810-16 is assigned to a package of 473 ml in 1 bottle of Nystatin, a human prescription drug labeled by Pharmaceutical Associates, Inc.. The product's dosage form is suspension and is administered via oral form.

    Is NDC 0121-0810 included in the NDC Directory?

    Yes, Nystatin with product code 0121-0810 is active and included in the NDC Directory. The product was first marketed by Pharmaceutical Associates, Inc. on February 01, 2016 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 0121-0810-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

    What is the 11-digit format for NDC 0121-0810-16?

    The 11-digit format is 00121081016. 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
    4-4-20121-0810-165-4-200121-0810-16