Ramelteon Tablet
NDC Package 70710-1344-3

11-digit billing NDC: 70710134403 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. This formulation utilizes a tablet delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1344 and is authorized under FDA application ANDA211567.

Identification & Billing

NDC Package Code
70710-1344-3
Package Description
30 TABLET in 1 BOTTLE
Product Code
70710-1344
11-Digit Billing Format
70710134403
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 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
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211567
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-23-2019
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70710-1344). Click a package code to view its specific billing and regulatory data.

70710-1344-1
100 TABLET in 1 BOTTLE
70710-1344-5
500 TABLET in 1 BOTTLE

* 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 70710-1344-3 identifies a specific commercial package of 30 tablet in 1 bottle of Ramelteon, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. 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 Zydus Pharmaceuticals Usa Inc. on July 23, 2019. The current certification is valid through December 31, 2027.

How is this Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710134403. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-4-1)
70710-1344-3
11-Digit CMS (5-4-2)
70710-1344-03

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