NDC Package 65216-123-02 Simethicone

Emulsion - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:

65216-123-02

Package Description:

25 kg in 1 DRUM

Product Code:

65216-123

Non-Proprietary Name:

Simethicone

Substance Name:

Dimethicone; Silicon Dioxide

Usage Information:

This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

11-Digit NDC Billing Format:

65216012302

Product Type:

Drug For Further Processing

Labeler Name:

Basildon Chemical Co. Ltd.

Dosage Form:

Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

Active Ingredient(s):

DIMETHICONE 1 kg/kg

SILICON DIOXIDE 1 kg/kg

Sample Package:

N/A

Marketing Category:

DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.

Start Marketing Date:

01-05-1940

Listing Expiration Date:

12-31-2025

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

65216 - Basildon Chemical Co. Ltd.
- 65216-123 -
  - 65216-123-02 - 25 kg in 1 DRUM

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
65216-123-01	200 kg in 1 DRUM

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 65216-123-02?

The NDC Packaged Code 65216-123-02 is assigned to an UNFINISHED drug package of 25 kg in 1 drum of Simethicone, drug for further processing labeled by Basildon Chemical Co. Ltd.. The product's dosage form is emulsion and is administered via form.

Is NDC 65216-123 included in the NDC Directory?

Yes, Simethicone is an UNFINISHED PRODUCT with code 65216-123 that is active and included in the NDC Directory. The product was first marketed by Basildon Chemical Co. Ltd. on January 05, 1940 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 11-digit format for NDC 65216-123-02?

The 11-digit format is 65216012302. 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	65216-123-02	5-4-2	65216-0123-02

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