NDC Package 52817-816-15 Acetic Acid

Solution Auricular (otic) - 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:

52817-816-15

Package Description:

1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

Product Code:

52817-816

Proprietary Name:

Acetic Acid

Non-Proprietary Name:

Acetic Acid

Substance Name:

Acetic Acid

Usage Information:

Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow. This medication may also contain drying ingredients such as glycerin or alcohol. Drying of the ear canal helps to cure the infection.

11-Digit NDC Billing Format:

52817081615

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 197305 - acetic acid 2 % Otic Solution

RxCUI: 197305 - acetic acid 20 MG/ML Otic Solution

Product Type:

Human Prescription Drug

Labeler Name:

Trupharma, Llc

Dosage Form:

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Administration Route(s):

Auricular (otic) - Administration to or by way of the ear.

Active Ingredient(s):

ACETIC ACID 20.65 mg/mL

Sample Package:

FDA Application Number:

ANDA040607

Marketing Category:

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

Start Marketing Date:

06-05-2020

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

52817 - Trupharma, Llc
- 52817-816 - Acetic Acid
  - 52817-816-15 - 1 BOTTLE in 1 CARTON / 15 mL 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 52817-816-15?

The NDC Packaged Code 52817-816-15 is assigned to a package of 1 bottle in 1 carton / 15 ml in 1 bottle of Acetic Acid, a human prescription drug labeled by Trupharma, Llc. The product's dosage form is solution and is administered via auricular (otic) form.

Is NDC 52817-816 included in the NDC Directory?

Yes, Acetic Acid with product code 52817-816 is active and included in the NDC Directory. The product was first marketed by Trupharma, Llc on June 05, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 52817-816-15?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 52817-816-15?

The 11-digit format is 52817081615. 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	52817-816-15	5-4-2	52817-0816-15

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