Mannitol Injection, Solution
NDC Package 0264-7578-20

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

Mannitol injection is 20% Mannitol Injection USP is indicated for:Promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.Reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass.Reduction of elevated intraocular pressure when the pressure cannot be lowered by other means.Promotion of urinary excretion of toxins. This formulation utilizes a injection, solution delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-7578 and is authorized under FDA application NDA020006.

Identification & Billing

NDC Package Code
0264-7578-20
Package Description
24 CONTAINER in 1 CASE / 250 mL in 1 CONTAINER
Product Code
0264-7578
11-Digit Billing Format
00264757820
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mannitol
Non-Proprietary Name
Mannitol
Substance Name
Mannitol
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MANNITOL 20 g/100mL
Pharmacologic Class
Usage Information
20% Mannitol Injection USP is indicated for:Promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.Reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass.Reduction of elevated intraocular pressure when the pressure cannot be lowered by other means.Promotion of urinary excretion of toxins.

Regulatory & Marketing

Labeler Name
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020006
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-26-1993
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 (0264-7578). Click a package code to view its specific billing and regulatory data.

0264-7578-10
24 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER

* 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 0264-7578-20 identifies a specific commercial package of 24 container in 1 case / 250 ml in 1 container of Mannitol, a human prescription drug labeled by B. Braun Medical Inc.. This injection, solution is formulated for intravenous use and contains mannitol 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 B. Braun Medical Inc. on July 26, 1993. The current certification is valid through December 31, 2026.

How is this B. Braun Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264757820. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0264-7578-20
11-Digit CMS (5-4-2)
00264-7578-20

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