NDC 71335-1183 Diclofenac Sodium And Misoprostol

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
71335-1183
Proprietary Name:
Diclofenac Sodium And Misoprostol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bryant Ranch Prepack
Labeler Code:
71335
Start Marketing Date: [9]
12-01-2016
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
AN;438
Score:
1

Product Packages

NDC Code 71335-1183-1

Package Description: 20 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Code 71335-1183-2

Package Description: 14 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Code 71335-1183-3

Package Description: 60 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Code 71335-1183-4

Package Description: 30 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Code 71335-1183-5

Package Description: 10 TABLET, DELAYED RELEASE in 1 BOTTLE

Product Details

What is NDC 71335-1183?

The NDC code 71335-1183 is assigned by the FDA to the product Diclofenac Sodium And Misoprostol which is product labeled by Bryant Ranch Prepack. The product's dosage form is . The product is distributed in 5 packages with assigned NDC codes 71335-1183-1 20 tablet, delayed release in 1 bottle , 71335-1183-2 14 tablet, delayed release in 1 bottle , 71335-1183-3 60 tablet, delayed release in 1 bottle , 71335-1183-4 30 tablet, delayed release in 1 bottle , 71335-1183-5 10 tablet, delayed release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Diclofenac Sodium And Misoprostol?

Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in 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 (5.2)].

Which are Diclofenac Sodium And Misoprostol UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Diclofenac Sodium And Misoprostol Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Diclofenac Sodium And Misoprostol?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Patient Education

Diclofenac and Misoprostol


The combination of diclofenac and misoprostol is used to relieve the pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints) in patients who have a high risk of developing stomach ulcers. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain and inflammation. Misoprostol is in a class of medications called prostaglandins. It prevents ulcers caused by diclofenac by protecting the stomach lining and decreasing stomach acid production.
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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".