NDC Package 70934-047-10 Nitrofurantoin Monohydrate/ Macrocrystalline

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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:

70934-047-10

Package Description:

10 CAPSULE in 1 BOTTLE, PLASTIC

Product Code:

70934-047

Proprietary Name:

Nitrofurantoin Monohydrate/ Macrocrystalline

Usage Information:

Nitrofurantoin monohydrate/macrocrystals capsules are 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 capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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 capsules 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 capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, 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:

70934004710

Labeler Name:

Denton Pharma, Inc. Dba Northwind Pharmaceuticals

Sample Package:

FDA Application Number:

NDA020064

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

11-27-2017

End Marketing Date:

07-31-2024

Listing Expiration Date:

07-31-2024

Exclude Flag:

Code Structure:

70934 - Denton Pharma, Inc. Dba Northwind Pharmaceuticals
- 70934-047 - Nitrofurantoin Monohydrate/ Macrocrystalline
  - 70934-047-10 - 10 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
70934-047-14	14 CAPSULE in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70934-047-10?

The NDC Packaged Code 70934-047-10 is assigned to a package of 10 capsule in 1 bottle, plastic of Nitrofurantoin Monohydrate/ Macrocrystalline, labeled by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The product's dosage form is and is administered via form.

Is NDC 70934-047 included in the NDC Directory?

No, Nitrofurantoin Monohydrate/ Macrocrystalline with product code 70934-047 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals on November 27, 2017 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 11-digit format for NDC 70934-047-10?

The 11-digit format is 70934004710. 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 5-3-2 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
5-3-2	70934-047-10	5-4-2	70934-0047-10

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