NDC Package 0480-3470-01 Nitrofurantoin (monohydrate/macrocrystals)

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

0480-3470-01

Package Description:

100 CAPSULE in 1 BOTTLE

Product Code:

0480-3470

Proprietary Name:

Nitrofurantoin (monohydrate/macrocrystals)

Usage Information:

Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.

11-Digit NDC Billing Format:

00480347001

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

Labeler Name:

Teva Pharmaceuticals Usa, Inc.

Sample Package:

FDA Application Number:

ANDA077066

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

09-09-2022

End Marketing Date:

07-31-2024

Listing Expiration Date:

07-31-2024

Exclude Flag:

Code Structure:

0480 - Teva Pharmaceuticals Usa, Inc.
- 0480-3470 - Nitrofurantoin (monohydrate/macrocrystals)
  - 0480-3470-01 - 100 CAPSULE in 1 BOTTLE

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 0480-3470-01?

The NDC Packaged Code 0480-3470-01 is assigned to a package of 100 capsule in 1 bottle of Nitrofurantoin (monohydrate/macrocrystals), labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is and is administered via form.

Is NDC 0480-3470 included in the NDC Directory?

No, Nitrofurantoin (monohydrate/macrocrystals) with product code 0480-3470 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on September 09, 2022 and its listing in the NDC Directory is set to expire on July 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0480-3470-01?

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 100.

What is the 11-digit format for NDC 0480-3470-01?

The 11-digit format is 00480347001. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0480-3470-01	5-4-2	00480-3470-01

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