Metronidazole500 Mg
NDC Package 70882-131-14

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Metronidazole500 Mg is symptomatic Trichomoniasis. Marketed by Cambridge Therapeutics Technologies, Llc, this product is identified by NDC 70882-131 and is authorized under FDA application ANDA070039.

Identification & Billing

NDC Package Code
70882-131-14
Package Description
14 TABLET, FILM COATED in 1 BOTTLE
Product Code
70882-131
11-Digit Billing Format
70882013114
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metronidazole500 Mg 500 Mg
Dosage Form
-
Usage Information
Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.Treatment of Asymptomatic Sexual Partners.T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection.Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess.In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus.Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets.INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B.fragilis group (B.fragilis, B.distasonis, B.ovatus, B.thetaiotaomicron, B.vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species.SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcusspecies, Peptostreptococcus species, and Fusobacterium species.GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B.fragilis group, Clostridium species, Peptococcusspecies, Peptostreptococcus species, and Fusobacterium species.BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species.BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group.CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group.LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.ENDOCARDITIS caused by Bacteroides species including the B.fragilis group.To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole 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.

Regulatory & Marketing

Labeler Name
Cambridge Therapeutics Technologies, Llc
FDA Application #
ANDA070039
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-13-2016
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70882-131-14 identifies a specific commercial package of 14 tablet, film coated in 1 bottle of Metronidazole500 Mg 500 Mg, labeled by Cambridge Therapeutics Technologies, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Cambridge Therapeutics Technologies, Llc on June 13, 2016. The current certification is valid through December 31, 2025.

How is this Cambridge Therapeutics Technologies, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70882013114. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70882-131-14
11-Digit CMS (5-4-2)
70882-0131-14

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.