Dolobid Tablet, Film Coated
NDC Package 74157-101-60

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

Package Information

Dolobid (diflunisal) tablets is diflunisal is used to relieve mild to moderate pain from various conditions. This formulation utilizes a tablet, film coated delivery system. Marketed by Ina Pharmaceutics Inc, this product is identified by NDC 74157-101 and is authorized under FDA application ANDA202845.

Identification & Billing

NDC Package Code
74157-101-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
74157-101
11-Digit Billing Format
74157010160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dolobid
Non-Proprietary Name
Diflunisal
Substance Name
Diflunisal
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIFLUNISAL 375 mg/1
Pharmacologic Class
Usage Information
Diflunisal is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

Regulatory & Marketing

Labeler Name
Ina Pharmaceutics Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA202845
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 74157-101-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Dolobid, a human prescription drug labeled by Ina Pharmaceutics Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, film coated is formulated for oral use and contains diflunisal 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 Ina Pharmaceutics Inc on August 19, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diflunisal is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

How is this Ina Pharmaceutics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74157010160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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:

10-Digit Format (5-3-2)
74157-101-60
11-Digit CMS (5-4-2)
74157-0101-60

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