Acetazolamide
NDC Package 53489-166-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Acetazolamide is used to prevent and reduce the symptoms of altitude sickness. Marketed by Mutual Pharmaceutical Company, Inc., this product is identified by NDC 53489-166 and is authorized under FDA application ANDA089752.

Identification & Billing

NDC Package Code
53489-166-10
Package Description
1000 TABLET in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
53489016610

Clinical Specifications

Proprietary Name
Acetazolamide
Dosage Form
-
Usage Information
Acetazolamide is used to prevent and reduce the symptoms of altitude sickness. This medication can decrease headache, tiredness, nausea, dizziness, and shortness of breath that can occur when you climb quickly to high altitudes (generally above 10,000 feet/3,048 meters). It is particularly useful in situations when you cannot make a slow ascent. The best ways to prevent altitude sickness are climbing slowly, stopping for 24 hours during the climb to allow the body to adjust to the new height, and taking it easy the first 1 to 2 days. This medication is also used with other medications to treat high pressure inside the eye due to certain types of glaucoma. Acetazolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. It works by decreasing the production of fluid inside the eye. It is also used to decrease a buildup of body fluids (edema) caused by heart failure or certain medications. Acetazolamide can work less well over time, so it is usually used only for a short period. It has also been used with other medications to treat certain types of seizures (petit mal and unlocalized seizures).

Regulatory & Marketing

Labeler Name
Mutual Pharmaceutical Company, Inc.
FDA Application #
ANDA089752
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-22-1998
End Marketing Date
10-01-2007
Listing Expiration
10-01-2007
Exclude Flag
D
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 (53489-166). Click a package code to view its specific billing and regulatory data.

100 TABLET in 1 BOTTLE, PLASTIC
50 TABLET in 1 BOTTLE, PLASTIC
250 TABLET in 1 BOTTLE, PLASTIC
500 TABLET in 1 BOTTLE, PLASTIC
20 TABLET in 1 BOTTLE, PLASTIC

* 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 53489-166-10 identifies a specific commercial package of 1000 tablet in 1 bottle, plastic of Acetazolamide, labeled by Mutual Pharmaceutical Company, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mutual Pharmaceutical Company, Inc. on June 22, 1998. The current certification is valid through October 01, 2007.

What are the primary indications for this medication?

Acetazolamide is used to prevent and reduce the symptoms of altitude sickness. This medication can decrease headache, tiredness, nausea, dizziness, and shortness of breath that can occur when you climb quickly to high altitudes (generally above 10,000 feet/3,048 meters). It is particularly useful in situations when you cannot make a slow ascent. The best ways to prevent altitude sickness are climbing slowly, stopping for 24 hours during the climb to allow the body to adjust to the new height, and taking it easy the first 1 to 2 days. This medication is also used with other medications to treat high pressure inside the eye due to certain types of glaucoma. Acetazolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. It works by decreasing the production of fluid inside the eye. It is also used to decrease a buildup of body fluids (edema) caused by heart failure or certain medications. Acetazolamide can work less well over time, so it is usually used only for a short period. It has also been used with other medications to treat certain types of seizures (petit mal and unlocalized seizures).

How is this Mutual Pharmaceutical Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53489016610. 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)
53489-166-10
11-Digit CMS (5-4-2)
53489-0166-10

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