NDC Package 70518-2602-0 Nitrofurantoin Macrocrystals

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Package Information
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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:

70518-2602-0

Package Description:

14 CAPSULE in 1 BOTTLE, PLASTIC

Product Code:

70518-2602

Proprietary Name:

Nitrofurantoin Macrocrystals

Usage Information:

Nitrofurantoin Capsules USP (Macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. 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 Capsules USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (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 Capsules USP (Macrocrystals) are predisposed to persistence or reappearance of bacteriuria. 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 Capsules USP (Macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules USP (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:

70518260200

Labeler Name:

Remedyrepack Inc.

Sample Package:

FDA Application Number:

ANDA073652

Marketing Category:

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

Start Marketing Date:

02-26-2020

End Marketing Date:

03-20-2025

Listing Expiration Date:

03-20-2025

Exclude Flag:

Code Structure:

70518 - Remedyrepack Inc.
- 70518-2602 - Nitrofurantoin Macrocrystals
  - 70518-2602-0 - 14 CAPSULE in 1 BOTTLE, PLASTIC

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 Code	Package Description
70518-2602-1	10 CAPSULE in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70518-2602-0?

The NDC Packaged Code 70518-2602-0 is assigned to a package of 14 capsule in 1 bottle, plastic of Nitrofurantoin Macrocrystals, labeled by Remedyrepack Inc.. The product's dosage form is and is administered via form.

Is NDC 70518-2602 included in the NDC Directory?

No, Nitrofurantoin Macrocrystals with product code 70518-2602 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Remedyrepack Inc. on February 26, 2020 and its listing in the NDC Directory is set to expire on March 20, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 70518-2602-0?

The 11-digit format is 70518260200. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	70518-2602-0	5-4-2	70518-2602-00

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