1. Home
  2. Labeler Index
  3. Advanced Rx Pharmacy Of Tennessee, Llc
  4. 80425-0272
  5. NDC Package Code: 80425-0272-1 Diclofenac Sodium And Misoprostol DR

NDC Package 80425-0272-1 Diclofenac Sodium And Misoprostol DR

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
80425-0272-1
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
80425-0272
Proprietary Name:
Diclofenac Sodium And Misoprostol DR
Non-Proprietary Name:
Diclofenac Sodium And Misoprostol
Substance Name:
Diclofenac Sodium; Misoprostol
Usage Information:
Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)] .
11-Digit NDC Billing Format:
80425027201
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Advanced Rx Pharmacy Of Tennessee, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DICLOFENAC SODIUM 75 mg/1
  • MISOPROSTOL 200 ug/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Prostaglandin Production - [PE] (Physiologic Effect)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Prostaglandin E1 Analog - [EPC] (Established Pharmacologic Class)
  • Prostaglandins E, Synthetic - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA020607
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    02-23-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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 80425-0272-1?

    The NDC Packaged Code 80425-0272-1 is assigned to a package of 60 tablet, film coated in 1 bottle of Diclofenac Sodium And Misoprostol DR, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 80425-0272 included in the NDC Directory?

    Yes, Diclofenac Sodium And Misoprostol DR with product code 80425-0272 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Pharmacy Of Tennessee, Llc on February 23, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 80425-0272-1?

    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 60.

    What is the 11-digit format for NDC 80425-0272-1?

    The 11-digit format is 80425027201. 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 5-4-1 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
    5-4-180425-0272-15-4-280425-0272-01