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  5. NDC Package Code: 70010-028-05 Ramelteon

NDC Package 70010-028-05 Ramelteon

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70010-028-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
70010-028
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:
70010002805
NDC to RxNorm Crosswalk:
  • RxCUI: 577348 - ramelteon 8 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Granules Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • RAMELTEON 8 mg/1
    • Pharmacologic Class(es):
  • Melatonin Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Melatonin Receptor Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213186
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-01-2020
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70010-028-01100 TABLET in 1 BOTTLE
    70010-028-0330 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70010-028-05?

    The NDC Packaged Code 70010-028-05 is assigned to a package of 500 tablet in 1 bottle of Ramelteon, a human prescription drug labeled by Granules Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 70010-028 included in the NDC Directory?

    Yes, Ramelteon with product code 70010-028 is active and included in the NDC Directory. The product was first marketed by Granules Pharmaceuticals Inc. on October 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70010-028-05?

    The 11-digit format is 70010002805. 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 5-3-2 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
    5-3-270010-028-055-4-270010-0028-05