Bonine Tablet, Chewable
NDC Package 65197-296-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Bonine (meclizine hydrochloride) tablets is dosage should be taken one hour before travel startsadults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor. This formulation utilizes a tablet, chewable delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-296 and is authorized under FDA application M009.

Identification & Billing

NDC Package Code
65197-296-08
Package Description
1 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code
65197-296
11-Digit Billing Format
65197029608
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bonine
Non-Proprietary Name
Meclizine Hydrochloride
Substance Name
Meclizine Hydrochloride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MECLIZINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Dosage should be taken one hour before travel startsadults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
FDA Application #
M009
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-15-2023
End Marketing Date
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65197-296). Click a package code to view its specific billing and regulatory data.

65197-296-12
1 BOTTLE in 1 BOX / 12 TABLET, CHEWABLE in 1 BOTTLE
65197-296-16
2 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK
65197-296-24
3 BLISTER PACK in 1 CARTON / 8 TABLET, CHEWABLE in 1 BLISTER PACK
65197-296-32
4 BLISTER PACK in 1 CARTON / 8 TABLET, CHEWABLE in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65197-296-08 identifies a specific commercial package of 1 blister pack in 1 box / 8 tablet, chewable in 1 blister pack of Bonine, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This tablet, chewable is formulated for oral use and contains meclizine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Wellspring Pharmaceutical Corporation on February 15, 2023.

How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197029608. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65197-296-08
11-Digit CMS (5-4-2)
65197-0296-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.