NDC Package 70482-076-30 Osmolex Er

Amantadine Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

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:
70482-076-30
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Osmolex Er
Non-Proprietary Name:
Amantadine
Substance Name:
Amantadine Hydrochloride
Usage Information:
This medication is used to treat Parkinson's disease. It is also used to treat certain movement disorders caused by some drugs (extrapyramidal reactions). This medication is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain. Different brands of this medication may have different uses. Do not change brands of this medication unless directed by your doctor.
11-Digit NDC Billing Format:
70482007630
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2044714 - amantadine 129 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2044714 - 24 HR amantadine 129 MG Extended Release Oral Tablet
  • RxCUI: 2044714 - amantadine 129 MG (as amantadine HCl 160 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 2044720 - Osmolex ER 129 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2044720 - 24 HR amantadine 129 MG Extended Release Oral Tablet [Osmolex]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Adamas Pharma, Llc
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA209410
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2018
    Listing Expiration Date:
    12-31-2025
    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
    70482-076-072 BLISTER PACK in 1 CARTON / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    70482-076-1414 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70482-076-30?

    The NDC Packaged Code 70482-076-30 is assigned to a package of 30 tablet, extended release in 1 bottle of Osmolex Er, a human prescription drug labeled by Adamas Pharma, Llc. The product's dosage form is tablet, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 70482-076 included in the NDC Directory?

    Yes, Osmolex Er with product code 70482-076 is active and included in the NDC Directory. The product was first marketed by Adamas Pharma, Llc on June 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 70482-076-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 70482-076-30?

    The 11-digit format is 70482007630. 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
    5-3-270482-076-305-4-270482-0076-30