Osmitrol Injection, Solution
NDC Package 0338-0357-03
Package Information
Osmitrol (mannitol) injection is oSMITROL Injection (Mannitol Injection, USP) is indicated for: The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established;The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass;The reduction of elevated intraocular pressure when the pressure cannot be lowered by other means, andPromoting the urinary excretion of toxic substances. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Company, this product is identified by NDC 0338-0357 and is authorized under FDA application NDA013684.
Identification & Billing
- RxCUI: 1791395 - mannitol 10 % in 500 ML Injection
- RxCUI: 1791395 - 500 ML mannitol 100 MG/ML Injection
- RxCUI: 1791395 - mannitol 10 % per 500 ML Injection
- RxCUI: 1791403 - mannitol 20 % in 250 ML Injection
- RxCUI: 1791403 - 250 ML mannitol 200 MG/ML Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0338 - Baxter Healthcare Company
- 0338-0357 - Osmitrol
- 0338-0357-03 - 500 mL in 1 BAG
- 0338-0357 - Osmitrol
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.
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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 (0338-0357). Click a package code to view its specific billing and regulatory data.
* 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 0338-0357-03 identifies a specific commercial package of 500 ml in 1 bag of Osmitrol, a human prescription drug labeled by Baxter Healthcare Company. This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package. 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 Baxter Healthcare Company on June 08, 1964. The current certification is valid through December 31, 2026.
How is this Baxter Healthcare Company product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338035703. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
