Acetazolamide Capsule, Extended Release
NDC Package 16729-331-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Acetazolamide capsules is acetazolamide is used to prevent and reduce the symptoms of altitude sickness. This formulation utilizes a capsule, extended release delivery system. Marketed by Accord Healthcare Inc., this product is identified by NDC 16729-331 and is authorized under FDA application ANDA207659.

Identification & Billing

NDC Package Code
16729-331-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
16729-331
11-Digit Billing Format
16729033101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 562524 - acetaZOLAMIDE 500 MG 12HR Extended Release Oral Capsule
  • RxCUI: 562524 - 12 HR acetazolamide 500 MG Extended Release Oral Capsule
  • RxCUI: 562524 - acetazolamide 500 MG 12 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Acetazolamide
Non-Proprietary Name
Acetazolamide
Substance Name
Acetazolamide
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAZOLAMIDE 500 mg/1
Pharmacologic Class
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
Accord Healthcare Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207659
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-19-2021
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 16729-331-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Acetazolamide, a human prescription drug labeled by Accord Healthcare Inc.. This capsule, extended release is formulated for oral use and contains acetazolamide 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 Accord Healthcare Inc. on November 19, 2021. The current certification is valid through December 31, 2026.

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 Accord Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729033101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
16729-331-01
11-Digit CMS (5-4-2)
16729-0331-01

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