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  5. NDC Package Code: 0121-1996-95 Nitrofurantoin Oral Suspension

NDC Package 0121-1996-95 Nitrofurantoin Oral Suspension

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:
0121-1996-95
Package Description:
10 CUP, UNIT-DOSE in 1 CASE / 10 mL in 1 CUP, UNIT-DOSE (0121-1996-10)
Product Code:
0121-1996
Proprietary Name:
Nitrofurantoin Oral Suspension
Non-Proprietary Name:
Nitrofurantoin Oral Suspension
Substance Name:
Nitrofurantoin
Usage Information:
Nitrofurantoin is an antibiotic used to treat or prevent certain bladder infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This medication should not be used in infants younger than 1 month old (see also Precautions section). This drug should not be used to treat infections outside the bladder (including kidney infections such as pyelonephritis or perinephric abscesses).
11-Digit NDC Billing Format:
00121199695
NDC to RxNorm Crosswalk:
  • RxCUI: 311989 - nitrofurantoin 25 MG in 5 mL Oral Suspension
  • RxCUI: 311989 - nitrofurantoin 5 MG/ML Oral Suspension
  • RxCUI: 311989 - nitrofurantoin 25 MG per 5 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pai Holdings, Llc Dba Pai Pharma
    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):
  • NITROFURANTOIN 25 mg/5mL
    • Pharmacologic Class(es):
  • Nitrofuran Antibacterial - [EPC] (Established Pharmacologic Class)
  • Nitrofurans - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA201355
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-10-2024
    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 0121-1996-95?

    The NDC Packaged Code 0121-1996-95 is assigned to a package of 10 cup, unit-dose in 1 case / 10 ml in 1 cup, unit-dose (0121-1996-10) of Nitrofurantoin Oral Suspension, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. The product's dosage form is suspension and is administered via oral form.

    Is NDC 0121-1996 included in the NDC Directory?

    Yes, Nitrofurantoin Oral Suspension with product code 0121-1996 is active and included in the NDC Directory. The product was first marketed by Pai Holdings, Llc Dba Pai Pharma on June 10, 2024 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 11-digit format for NDC 0121-1996-95?

    The 11-digit format is 00121199695. 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
    4-4-20121-1996-955-4-200121-1996-95