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  4. NDC Product Code: 0440-0605 Prasugrel

NDC 0440-0605 Prasugrel

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0440-0605?
  5. Prasugrel Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0440-0605
Proprietary Name:
Prasugrel
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Liberty Pharmaceuticals, Inc.
Labeler Code:
0440
Product Label ID:
60853d14-ac2a-4e48-9c0c-afd8069b83c6
Start Marketing Date: [9]
10-17-2017
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
OVAL (C48345)
Size(s):
10 MM
12 MM
Imprint(s):
P5
P1
Score:
1

Product Packages

NDC Code 0440-0605-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 0440-0605?

The NDC code 0440-0605 is assigned by the FDA to the product Prasugrel which is product labeled by Liberty Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0440-0605-30 30 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 Prasugrel?

Prasugrel tablets is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:•Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).•Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)].

Which are Prasugrel UNII Codes?

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

Which are Prasugrel 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 Prasugrel?

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:

* Please review the disclaimer below.

Patient Education

Prasugrel


Prasugrel is used along with aspirin to prevent serious or life-threatening problems with the heart and blood vessels in people who have had a heart attack or severe chest pain and have been treated with angioplasty (procedure to open the blood vessels that supply blood to the heart). Prasugrel is in a class of medications called anti-platelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.
[Learn More]


Blood Thinners


What are blood thinners?

Blood thinners are medicines that prevent blood clots from forming. They do not break up clots that you already have. But they can stop those clots from getting bigger. It's important to treat blood clots, because clots in your blood vessels and heart can cause heart attacks, strokes, and blockages.

Who needs blood thinners?

You may need a blood thinner if you have:

What are the different types of blood thinners?

There are different types of blood thinners:

  • Anticoagulants, such as heparin or warfarin (also called Coumadin), slow down your body's process of making clots.
  • Antiplatelets, such as aspirin and clopidogrel, prevent blood cells called platelets from clumping together to form a clot. Antiplatelets are mainly taken by people who have had a heart attack or stroke.

How can I take blood thinners safely?

When you take a blood thinner, follow the directions carefully. Blood thinners may interact with certain foods, medicines, vitamins, and alcohol. Make sure that your health care provider knows all of the medicines and supplements you are using.

You may need regular blood tests to check how well your blood is clotting. It is important to make sure that you're taking enough medicine to prevent clots, but not so much that it causes bleeding.

What are the side effects of blood thinners?

Bleeding is the most common side effect of blood thinners. They can also cause an upset stomach, nausea, and diarrhea.

Other possible side effects can depend on which type of blood thinner that you are taking.

Call your provider if you have any sign of serious bleeding, such as:

  • Menstrual bleeding that is much heavier than normal
  • Red or brown urine
  • Bowel movements that are red or black
  • Bleeding from the gums or nose that does not stop quickly
  • Vomit that is brown or bright red
  • Coughing up something red
  • Severe pain, such as a headache or stomachache
  • Unusual bruising
  • A cut that does not stop bleeding
  • A serious fall or bump on the head
  • Dizziness or weakness

[Learn More]


* 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".