Acetazolamide Capsule
NDC Package 70710-1591-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-1591 and is authorized under FDA application ANDA205301.

Identification & Billing

NDC Package Code
70710-1591-3
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
70710-1591
11-Digit Billing Format
70710159103
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 - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
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
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205301
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-08-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70710-1591). Click a package code to view its specific billing and regulatory data.

70710-1591-0
1000 CAPSULE in 1 BOTTLE
70710-1591-1
100 CAPSULE in 1 BOTTLE
70710-1591-4
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
70710-1591-5
500 CAPSULE in 1 BOTTLE
70710-1591-9
90 CAPSULE in 1 BOTTLE

* 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 70710-1591-3 identifies a specific commercial package of 30 capsule in 1 bottle of Acetazolamide, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This capsule 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 Zydus Pharmaceuticals (usa) Inc. on May 08, 2019. 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 Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710159103. 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 (5-4-1)
70710-1591-3
11-Digit CMS (5-4-2)
70710-1591-03

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