NDC Package 0115-1121-10 Galantamine Hydrobromide

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

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:

0115-1121-10

Package Description:

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Product Code:

0115-1121

Proprietary Name:

Galantamine Hydrobromide

Usage Information:

Galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

11-Digit NDC Billing Format:

00115112110

Labeler Name:

Impax Generics

Sample Package:

FDA Application Number:

ANDA078484

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

05-27-2009

End Marketing Date:

03-31-2014

Listing Expiration Date:

03-31-2014

Exclude Flag:

Code Structure:

0115 - Impax Generics
- 0115-1121 - Galantamine Hydrobromide
  - 0115-1121-10 - 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

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 Code	Package Description
0115-1121-03	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
0115-1121-08	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0115-1121-10?

The NDC Packaged Code 0115-1121-10 is assigned to a package of 90 capsule, extended release in 1 bottle of Galantamine Hydrobromide, labeled by Impax Generics. The product's dosage form is and is administered via form.

Is NDC 0115-1121 included in the NDC Directory?

The product was first marketed by Impax Generics on May 27, 2009 and its listing in the NDC Directory is set to expire on March 31, 2014 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0115-1121-10?

The 11-digit format is 00115112110. 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 4-4-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0115-1121-10	5-4-2	00115-1121-10

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