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  4. NDC Product Code: 70347-081 Yosprala

NDC 70347-081 Yosprala

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70347-081?
  5. Yosprala Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 70347-081 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
70347-081
Proprietary Name:
Yosprala
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aralez Pharmaceuticals Us Inc.
Labeler Code:
70347
Product Label ID:
73f74f6d-e624-4551-8924-1c747ffb2140
FDA Application Number: [6]
NDA205103
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
09-14-2016
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - BLUE-GREEN)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
81;40
Score:
1

Code Structure Chart

Product Details

What is NDC 70347-081?

The NDC code 70347-081 is assigned by the FDA to the product Yosprala which is product labeled by Aralez Pharmaceuticals Us Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 70347-081-30 30 tablet, film coated in 1 bottle , 70347-081-90 90 tablet, film coated 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 Yosprala?

This combination product contains two medications: aspirin and omeprazole. It is used to reduce the risk of stroke or heart attack in people who have had "mini-strokes" (transient ischemic attacks), or a stroke due to a blood clot, or who have heart disease. This product is used by people who are at risk for developing ulcers while taking aspirin. Aspirin belongs to a class of drugs known as antiplatelets. It has many uses, such as for pain relief or to reduce a fever. In low doses (such as this product), it is used to prevent harmful blood clots that can cause a stroke or heart attack. It works by stopping platelets in your blood from clumping together to form clots. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). It works by decreasing the amount of acid your stomach makes. This effect helps prevent ulcers and other stomach-related problems (such as heartburn) that can be caused by aspirin. This medication contains a delayed-release form of aspirin. It should not be used to treat conditions that require an immediate-release form of aspirin, such as right after a heart attack or before certain heart procedures (such as percutaneous coronary intervention-PCI). Also, this combination product is not the same as taking aspirin and omeprazole separately.

Which are Yosprala UNII Codes?

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

Which are Yosprala 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 Yosprala?

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: 1811631 - aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet
  • RxCUI: 1811631 - ASA 81 MG / Omeprazole 40 MG Delayed Release Oral Tablet
  • RxCUI: 1811632 - aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet
  • RxCUI: 1811632 - ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet
  • RxCUI: 1811916 - Yosprala 325 MG / 40 MG Delayed Release Oral Tablet

* 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".