Rohto Liquid
NDC Package 66613-8459-1

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

Package Information

Rohto (hypromellose, povidone) liquids is put 1 or 2 drops in the affected eye(s) as neededtightly snap on cap to seal Other informationdo not store above 25 OC (77 OF). This formulation utilizes a liquid delivery system. Marketed by Rohto Pharmaceutical Co., Ltd., this product is identified by NDC 66613-8459 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
66613-8459-1
Package Description
1 BOTTLE, DISPENSING in 1 CARTON / 18 mL in 1 BOTTLE, DISPENSING
Product Code
66613-8459
11-Digit Billing Format
66613845901
RxNorm Crosswalk
  • RxCUI: 2604775 - hypromellose 0.3 % / povidone 0.5 % Ophthalmic Solution
  • RxCUI: 2604775 - hypromellose 3 MG/ML / povidone 5 MG/ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Rohto Dual Light Relief
Non-Proprietary Name
Hypromellose, Povidone
Substance Name
Hypromellose, Unspecified; Povidone
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Usage Information
Put 1 or 2 drops in the affected eye(s) as neededtightly snap on cap to seal Other informationdo not store above 25 OC (77 OF)

Regulatory & Marketing

Labeler Name
Rohto Pharmaceutical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-30-2024
Listing Expiration
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66613-8459-1 identifies a specific commercial package of 1 bottle, dispensing in 1 carton / 18 ml in 1 bottle, dispensing of Rohto Dual Light Relief, a human over the counter drug labeled by Rohto Pharmaceutical Co., Ltd.. This liquid is formulated for ophthalmic use and contains hypromellose, unspecified; povidone 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 Rohto Pharmaceutical Co., Ltd. on May 30, 2024. The current certification is valid through December 31, 2026.

How is this Rohto Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66613845901. 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 (5-4-1)
66613-8459-1
11-Digit CMS (5-4-2)
66613-8459-01

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