Dabigatran Etexilate Capsule
NDC Package 59651-975-61

11-digit billing NDC: 59651097561
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Dabigatran Etexilate capsules are contraindicated in patients with:Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)]Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)]. This formulation utilizes a capsule delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 59651-975 and is authorized under FDA application ANDA208039.

Identification & Billing

NDC Package Code
59651-975-61
Package Description
10 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK
Product Code
59651-975
11-Digit Billing Format
59651097561
RxNorm Crosswalk
  • RxCUI: 1037045 - dabigatran etexilate 150 MG Oral Capsule
  • RxCUI: 1037045 - dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule
  • RxCUI: 1037179 - dabigatran etexilate 75 MG Oral Capsule
  • RxCUI: 1037179 - dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral Capsule
  • RxCUI: 1723476 - dabigatran etexilate 110 MG Oral Capsule

Clinical Specifications

Proprietary Name
Dabigatran Etexilate
Non-Proprietary Name
Dabigatran Etexilate
Substance Name
Dabigatran Etexilate Mesylate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DABIGATRAN ETEXILATE MESYLATE 150 mg/1
Pharmacologic Class
Usage Information
Dabigatran etexilate capsules are contraindicated in patients with:Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)]Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)]

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA208039
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-14-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59651-975). Click a package code to view its specific billing and regulatory data.

59651-975-60
60 CAPSULE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59651-975-61 identifies a specific commercial package of 10 blister pack in 1 carton / 6 capsule in 1 blister pack of Dabigatran Etexilate, a human prescription drug labeled by Aurobindo Pharma Limited. This capsule is formulated for oral use and contains dabigatran etexilate mesylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aurobindo Pharma Limited on May 14, 2025. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59651097561. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59651-975-61
11-Digit CMS (5-4-2)
59651-0975-61

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.