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  4. NDC Product Code: 21695-899 Pradaxa

NDC 21695-899 Pradaxa

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 21695-899?
  5. Pradaxa 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) 21695-899 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:
21695-899
Proprietary Name:
Pradaxa
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Product Label ID:
5db7f199-8752-4d24-85f7-e34ca8f4d02e
FDA Application Number: [6]
NDA022512
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-26-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE)
WHITE (C48325 - CREAM COLORED)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
R150;
Score:
1

Code Structure Chart

Product Details

What is NDC 21695-899?

The NDC code 21695-899 is assigned by the FDA to the product Pradaxa which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 21695-899-60 60 capsule 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 Pradaxa?

Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body. Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.

Which are Pradaxa UNII Codes?

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

  • DABIGATRAN ETEXILATE MESYLATE (UNII: SC7NUW5IIT)
  • DABIGATRAN ETEXILATE (UNII: 2E18WX195X) (Active Moiety)

Which are Pradaxa 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 Pradaxa?

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: 1037045 - dabigatran etexilate 150 MG Oral Capsule
  • RxCUI: 1037045 - dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule
  • RxCUI: 1037049 - Pradaxa 150 MG Oral Capsule
  • RxCUI: 1037049 - dabigatran etexilate 150 MG Oral Capsule [Pradaxa]
  • RxCUI: 1037049 - Pradaxa 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral Capsule

* 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".