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  5. NDC Package Code: 70518-4257-0 Ramelteon

NDC Package 70518-4257-0 Ramelteon

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
70518-4257-0
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
70518-4257
Proprietary Name:
Ramelteon
Non-Proprietary Name:
Ramelteon
Substance Name:
Ramelteon
Usage Information:
This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night's rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).
11-Digit NDC Billing Format:
70518425700
NDC to RxNorm Crosswalk:
RxCUI: 577348 - ramelteon 8 MG Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Remedyrepack Inc.
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
RAMELTEON 8 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA213815
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-20-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

Frequently Asked Questions

What is NDC 70518-4257-0?

The NDC Packaged Code 70518-4257-0 is assigned to a package of 30 tablet, film coated in 1 bottle, plastic of Ramelteon, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 70518-4257 included in the NDC Directory?

Yes, Ramelteon with product code 70518-4257 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on January 20, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 70518-4257-0?

The 11-digit format is 70518425700. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-170518-4257-05-4-270518-4257-00