Diclofenac Sodium Tablet, Delayed Release
NDC Package 63629-2011-1

11-digit billing NDC: 63629201101 · Billing unit: EA · 6000 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diclofenac Sodium tablets is carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. This formulation utilizes a tablet, delayed release delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-2011 and is authorized under FDA application ANDA075185.

Identification & Billing

NDC Package Code
63629-2011-1
Package Description
12 BOTTLE, PLASTIC in 1 BOX / 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
63629-2011
11-Digit Billing Format
63629201101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6000 EA
RxNorm Crosswalk
RxCUI: 855926 - diclofenac sodium 75 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Diclofenac Sodium Delayed Release
Non-Proprietary Name
Diclofenac Sodium
Substance Name
Diclofenac Sodium
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DICLOFENAC SODIUM 75 mg/1
Pharmacologic Class
Usage Information
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac is indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA075185
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-13-1998
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 63629-2011-1 identifies a specific commercial package of 12 bottle, plastic in 1 box / 500 tablet, delayed release in 1 bottle, plastic of Diclofenac Sodium Delayed Release, a human prescription drug labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 6000 billable units per package. This tablet, delayed release is formulated for oral use and contains diclofenac sodium 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 Bryant Ranch Prepack on November 13, 1998. The current certification is valid through December 31, 2026.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629201101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6000 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 (5-4-1)
63629-2011-1
11-Digit CMS (5-4-2)
63629-2011-01

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