Yosprala
NDC 70347-325

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70347-325?
  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.

Yosprala is a NDA-approved product labeled by Aralez Pharmaceuticals Us Inc.. This combination product contains two medications: aspirin and omeprazole. It is supplied as a blue product. This product entry covers the primary NDC 70347-325 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
70347-325
Proprietary Name:
Yosprala
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
09-14-2016
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I

Product Characteristics

Color(s):
BLUE (C48333 - BLUE-GREEN)
Shape:
OVAL (C48345)
Size(s):
10 MM
15 MM
Imprint(s):
81;40
325;40
Score:
1

Code Structure Chart

Product Details

What is NDC 70347-325?

The NDC code 70347-325 is assigned by the FDA to the product Yosprala. This pharmaceutical product is labeled by Aralez Pharmaceuticals Us Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 70347-325-30, 70347-325-90. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".