Ramelteon Tablet
NDC Package 50268-708-15

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ramelteon tablets is a medication used to treat sleeplessness (insomnia). This formulation utilizes a tablet delivery system. Marketed by Avpak, this product is identified by NDC 50268-708 and is authorized under FDA application ANDA091693.

Identification & Billing

NDC Package Code
50268-708-15
Package Description
50 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK (50268-708-11)
Product Code
50268-708
11-Digit Billing Format
50268070815
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA
RxNorm Crosswalk
RxCUI: 577348 - ramelteon 8 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ramelteon
Non-Proprietary Name
Ramelteon
Substance Name
Ramelteon
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RAMELTEON 8 mg/1
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Avpak
Product Type
Human Prescription Drug
FDA Application #
ANDA091693
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-06-2021
End Marketing Date
07-09-2026
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 50268-708-15 identifies a specific commercial package of 50 blister pack in 1 box / 1 tablet in 1 blister pack (50268-708-11) of Ramelteon, a human prescription drug labeled by Avpak. This tablet is formulated for oral use and contains ramelteon 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 Avpak on January 06, 2021.

What are the primary indications for this medication?

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).

How is this Avpak product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50268070815. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 total billable units per package. 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)
50268-708-15
11-Digit CMS (5-4-2)
50268-0708-15

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