Parox
NDC Package 83658-016-01

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 inactivated by the FDA.

Parox is this product does not contain directions or complete warnings for adult use.Do not give more than directed (see overdose warning)Shake well before using,  ml= milliliterFind the right dose on chart below. Marketed by Sj Incorporation Ltd, this product is identified by NDC 83658-016 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
83658-016-01
Package Description
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code
83658-016
11-Digit Billing Format
83658001601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Parox
Dosage Form
-
Usage Information
This product does not contain directions or complete warnings for adult use.Do not give more than directed (see overdose warning)Shake well before using,  ml= milliliterFind the right dose on chart below. If possible, use weight to confirm, otherwise use ageRemove the child protective cap and squeeze your child's dose in to the dosing cupRepeat dose every 4 hours while symptoms lastDo not give more than 5 times in 24 hours or as directed by a doctorAttention: Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
Sj Incorporation Ltd
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-25-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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 83658-016-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 ml in 1 bottle of Parox, labeled by Sj Incorporation Ltd. 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 Sj Incorporation Ltd on May 25, 2024. The current certification is valid through December 31, 2025.

How is this Sj Incorporation Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83658001601. 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)
83658-016-01
11-Digit CMS (5-4-2)
83658-0016-01

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