NDC Package 53703-800-16 Dicyclomine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

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:

53703-800-16

Package Description:

473 mL in 1 BOTTLE

Product Code:

53703-800

Proprietary Name:

Dicyclomine Hydrochloride

Usage Information:

Dicyclomine hydrochloride oral solution is indicated for the treatment of functional bowel/irritable bowel syndrome.

11-Digit NDC Billing Format:

53703080016

Billing Unit:

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

NDC to RxNorm Crosswalk:

473 ML

Labeler Name:

Entera Health, Inc.

Sample Package:

Start Marketing Date:

04-27-2015

Listing Expiration Date:

12-31-2018

Exclude Flag:

Code Structure:

53703 - Entera Health, Inc.
- 53703-800 - Dicyclomine Hydrochloride
  - 53703-800-16 - 473 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 53703-800-16?

The NDC Packaged Code 53703-800-16 is assigned to a package of 473 ml in 1 bottle of Dicyclomine Hydrochloride, labeled by Entera Health, Inc.. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package.

Is NDC 53703-800 included in the NDC Directory?

No, Dicyclomine Hydrochloride with product code 53703-800 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Entera Health, Inc. on April 27, 2015 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 53703-800-16?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 53703-800-16?

The 11-digit format is 53703080016. 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	53703-800-16	5-4-2	53703-0800-16

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