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  5. NDC Package Code: 63629-8680-1 Metronidazole Vaginal

NDC Package 63629-8680-1 Metronidazole Vaginal

View Billable Units, 11-Digit Format, RxNorm

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 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:
63629-8680-1
Package Description:
1 TUBE in 1 CARTON / 70 g in 1 TUBE
Product Code:
63629-8680
Proprietary Name:
Metronidazole Vaginal
Usage Information:
Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
11-Digit NDC Billing Format:
63629868001
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
70 GM
Labeler Name:
Bryant Ranch Prepack
Sample Package:
No
FDA Application Number:
ANDA211786
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-08-2019
End Marketing Date:
09-23-2024
Listing Expiration Date:
09-23-2024
Exclude Flag:
D
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 63629-8680-1?

The NDC Packaged Code 63629-8680-1 is assigned to a package of 1 tube in 1 carton / 70 g in 1 tube of Metronidazole Vaginal, labeled by Bryant Ranch Prepack. The product's dosage form is and is administered via form.This product is billed per "GM" gram and contains an estimated amount of 70 billable units per package.

Is NDC 63629-8680 included in the NDC Directory?

No, Metronidazole Vaginal with product code 63629-8680 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Bryant Ranch Prepack on July 08, 2019 and its listing in the NDC Directory is set to expire on September 23, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 63629-8680-1?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 70.

What is the 11-digit format for NDC 63629-8680-1?

The 11-digit format is 63629868001. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-163629-8680-15-4-263629-8680-01