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  5. NDC Package Code: 10544-949-14 Diclofenac Sodium And Misoprostol

NDC Package 10544-949-14 Diclofenac Sodium And Misoprostol

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
10544-949-14
Package Description:
14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
10544-949
Proprietary Name:
Diclofenac Sodium And Misoprostol
Usage Information:
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS). DICLOFENAC SODIUM/MISOPROSTOL TABLETS SHOULD NOT BE TAKEN BY PREGNANT WOMEN (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. DICLOFENAC SODIUM/MISOPROSTOL TABLETS should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-­inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID (see WARNINGS) . In such patients, diclofenac sodium and misoprostol delayed-release tablets may be prescribed if the patient: has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.is capable of complying with effective contraceptive measures.has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.will begin diclofenac sodium and misoprostol delayed-release tablets only on the second or third day of the next normal menstrual period.Cardiovascular RiskNSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS). Diclofenac sodium and misoprostol delayed-release tablets are contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Gastrointestinal RiskNSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
11-Digit NDC Billing Format:
10544094914
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
14 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1359105 - diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet
  • RxCUI: 1359105 - diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet
  • RxCUI: 1359105 - diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet
  • RxCUI: 1359105 - diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet
    • Labeler Name:
    Blenheim Pharmacal, Inc.
    Sample Package:
    No
    Start Marketing Date:
    10-07-2015
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 10544-949-14?

    The NDC Packaged Code 10544-949-14 is assigned to a package of 14 tablet, delayed release in 1 bottle, plastic of Diclofenac Sodium And Misoprostol, labeled by Blenheim Pharmacal, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package.

    Is NDC 10544-949 included in the NDC Directory?

    No, Diclofenac Sodium And Misoprostol with product code 10544-949 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Blenheim Pharmacal, Inc. on October 07, 2015 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 10544-949-14?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 14.

    What is the 11-digit format for NDC 10544-949-14?

    The 11-digit format is 10544094914. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-210544-949-145-4-210544-0949-14