Dimethyl Sulfoxide Irrigant
NDC Package 84897-052-01

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

Package Information

Dimethyl Sulfoxide irrigants is a medication used to treat a certain bladder condition (interstitial cystitis). This formulation utilizes a irrigant delivery system. Marketed by Renova Pharmaceuticals Llc, this product is identified by NDC 84897-052 and is authorized under FDA application ANDA220173.

Identification & Billing

NDC Package Code
84897-052-01
Package Description
1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS
Product Code
84897-052
11-Digit Billing Format
84897005201

Clinical Specifications

Proprietary Name
Dimethyl Sulfoxide
Non-Proprietary Name
Dimethyl Sulfoxide
Substance Name
Dimethyl Sulfoxide
Dosage Form
Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.
Administration Route
Intravesical - Administration within the bladder.
Active Ingredient(s)
DIMETHYL SULFOXIDE .54 g/mL
Usage Information
This medication is used to treat a certain bladder condition (interstitial cystitis). Dimethyl sulfoxide is also known as DMSO. It is believed to reduce swelling and pain due to interstitial cystitis and may improve blood supply to the treated area.

Regulatory & Marketing

Labeler Name
Renova Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA220173
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2025
Listing Expiration
12-31-2027
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 84897-052-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 50 ml in 1 vial, glass of Dimethyl Sulfoxide, a human prescription drug labeled by Renova Pharmaceuticals Llc. This irrigant is formulated for intravesical use and contains dimethyl sulfoxide 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 Renova Pharmaceuticals Llc on December 01, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain bladder condition (interstitial cystitis). Dimethyl sulfoxide is also known as DMSO. It is believed to reduce swelling and pain due to interstitial cystitis and may improve blood supply to the treated area.

How is this Renova Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84897005201. 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)
84897-052-01
11-Digit CMS (5-4-2)
84897-0052-01

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