NDC Package 61825-303-14 Oravig

Miconazole Tablet Buccal - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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:

61825-303-14

Package Description:

14 TABLET in 1 BOTTLE

Product Code:

61825-303

Proprietary Name:

Oravig

Non-Proprietary Name:

Miconazole

Substance Name:

Miconazole

Usage Information:

This medication is used to treat fungal infection in the mouth or throat. Miconazole is known as an azole antifungal drug. It works by stopping the growth of fungus.

11-Digit NDC Billing Format:

61825030314

Billing Unit:

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

NDC to RxNorm Crosswalk:

14 EA

NDC to RxNorm Crosswalk:

RxCUI: 998548 - miconazole 50 MG Buccal Tablet

RxCUI: 998548 - miconazole nitrate 50 MG Buccal Tablet

RxCUI: 998550 - Oravig 50 MG Buccal Tablet

RxCUI: 998550 - miconazole nitrate 50 MG Buccal Tablet [Oravig]

Product Type:

Human Prescription Drug

Labeler Name:

Galt Pharmaceuticals, Llc

Dosage Form:

Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Administration Route(s):

Buccal - Administration directed toward the cheek, generally from within the mouth.

Active Ingredient(s):

MICONAZOLE 50 mg/1

Pharmacologic Class(es):

Azole Antifungal - [EPC] (Established Pharmacologic Class)

Azoles - [CS]

Sample Package:

FDA Application Number:

NDA022404

Marketing Category:

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

Start Marketing Date:

12-31-2021

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

61825 - Galt Pharmaceuticals, Llc
- 61825-303 - Oravig
  - 61825-303-14 - 14 TABLET 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 61825-303-14?

The NDC Packaged Code 61825-303-14 is assigned to a package of 14 tablet in 1 bottle of Oravig, a human prescription drug labeled by Galt Pharmaceuticals, Llc. The product's dosage form is tablet and is administered via buccal form.This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package.

Is NDC 61825-303 included in the NDC Directory?

Yes, Oravig with product code 61825-303 is active and included in the NDC Directory. The product was first marketed by Galt Pharmaceuticals, Llc on December 31, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61825-303-14?

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 14.

What is the 11-digit format for NDC 61825-303-14?

The 11-digit format is 61825030314. 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	61825-303-14	5-4-2	61825-0303-14

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