NDC 0548-5631 Enoxaparin Sodium

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:
0548-5631
Proprietary Name:
Enoxaparin Sodium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Amphastar Pharmaceuticals, Inc.
Labeler Code:
0548
Start Marketing Date: [9]
09-19-2011
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 0548-5631-00

Package Description: 10 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE

Price per Unit: $12.13900 per ML

Product Details

What is NDC 0548-5631?

The NDC code 0548-5631 is assigned by the FDA to the product Enoxaparin Sodium which is product labeled by Amphastar Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0548-5631-00 10 syringe in 1 carton / .3 ml in 1 syringe. 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 Enoxaparin Sodium?

Enoxaparin is used to prevent and treat harmful blood clots. This helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of clotting proteins in the blood. Enoxaparin is an anticoagulant, also known as a "blood thinner." It is a type of heparin. Conditions which increase your risk of developing blood clots include certain types of surgeries (such as knee/hip replacement, abdominal), long periods of being immobile, certain types of heart attack, and a specific type of chest pain called unstable angina. For some medical conditions, enoxaparin may be used in combination with other "blood thinners."

Which are Enoxaparin Sodium UNII Codes?

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

Which are Enoxaparin Sodium 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 Enoxaparin Sodium?

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: 854228 - enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe
  • RxCUI: 854228 - 0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe
  • RxCUI: 854228 - 0.3 ML ENX sodium 100 MG/ML Prefilled Syringe
  • RxCUI: 854228 - enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe
  • RxCUI: 854235 - enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe

* Please review the disclaimer below.

Patient Education

Enoxaparin Injection


Enoxaparin is used to prevent blood clots in the leg in patients who are on bedrest or who are having hip replacement, knee replacement, or stomach surgery. It is used in combination with aspirin to prevent complications from angina (chest pain) and heart attacks. It is also used in combination with warfarin to treat blood clots in the leg. Enoxaparin is in a class of medications called low molecular weight heparins. It works by stopping the formation of substances that cause clots.
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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".