Bonine
NDC Package 65197-616-16

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Bonine is ■ dosage should be taken 30 minutes before you begin motion activity.■ adults and children 12 years and over: take 1 to 2 tablets every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor.■ Children 6 to under 12 years of age: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-616 and is authorized under FDA application M009.

Identification & Billing

NDC Package Code
65197-616-16
Package Description
2 BLISTER PACK in 1 BOX / 8 TABLET in 1 BLISTER PACK
Product Code
65197-616
11-Digit Billing Format
65197061616

Clinical Specifications

Proprietary Name
Bonine Faster-acting
Dosage Form
-
Usage Information
■ dosage should be taken 30 minutes before you begin motion activity.■ adults and children 12 years and over: take 1 to 2 tablets every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor.■ Children 6 to under 12 years of age: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor.

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
FDA Application #
M009
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2023
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65197-616-16 identifies a specific commercial package of 2 blister pack in 1 box / 8 tablet in 1 blister pack of Bonine Faster-acting, labeled by Wellspring Pharmaceutical Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Wellspring Pharmaceutical Corporation on May 01, 2023. The current certification is valid through April 30, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197061616. 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)
65197-616-16
11-Digit CMS (5-4-2)
65197-0616-16

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