Dimentho
NDC Package 71905-300-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dimentho is diclofenac Sodium is contraindicated in the following patients:Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. Marketed by Levins Pharmaceuticals, Llc, this product is identified by NDC 71905-300 and is authorized under FDA application ANDA203818.

Identification & Billing

NDC Package Code
71905-300-01
Package Description
1 KIT in 1 CARTON * 150 mL in 1 BOTTLE * 89 mL in 1 BOTTLE
Product Code
71905-300
11-Digit Billing Format
71905030001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dimentho
Dosage Form
-
Usage Information
Diclofenac Sodium is contraindicated in the following patients:Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. [see Warnings and Precautions (5.7, 5.9)].History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)].In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ].

Regulatory & Marketing

Labeler Name
Levins Pharmaceuticals, Llc
FDA Application #
ANDA203818
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2019
Listing Expiration
12-31-2020
Exclude Flag
I
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 71905-300-01 identifies a specific commercial package of 1 kit in 1 carton * 150 ml in 1 bottle * 89 ml in 1 bottle of Dimentho, labeled by Levins Pharmaceuticals, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Levins Pharmaceuticals, Llc on October 01, 2019. The current certification is valid through December 31, 2020.

How is this Levins Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71905030001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
71905-300-01
11-Digit CMS (5-4-2)
71905-0300-01

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