Acetazolamide Sodium Injection, Powder, Lyophilized, For Solution
NDC Package 63552-116-99

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Acetazolamide Sodium injection is a medication used with other medications to treat high pressure inside the eye due to certain types of glaucoma. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-116.

Identification & Billing

NDC Package Code
63552-116-99
Package Description
99 VIAL in 1 CASE / 10 mL in 1 VIAL
Product Code
63552-116
11-Digit Billing Format
63552011699

Clinical Specifications

Proprietary Name
Acetazolamide Sodium
Non-Proprietary Name
Acetazolamide Sodium
Substance Name
Acetazolamide Sodium
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Active Ingredient(s)
ACETAZOLAMIDE SODIUM 500 mg/5mL
Usage Information
This medication is 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
Patheon Manufacturing Services Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-10-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 63552-116-99 identifies a specific commercial package of 99 vial in 1 case / 10 ml in 1 vial of Acetazolamide Sodium (UNFINISHED drug), drug for further processing labeled by Patheon Manufacturing Services Llc. This injection, powder, lyophilized, for solution is formulated for use and contains acetazolamide sodium 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 Patheon Manufacturing Services Llc on December 10, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is 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 Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552011699. 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)
63552-116-99
11-Digit CMS (5-4-2)
63552-0116-99

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