NDC Package 0904-7254-68 Dabigatran Etexilate

Capsule, Coated Pellets Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0904-7254-68
Package Description:
6 BLISTER PACK in 1 CARTON / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7254-35)
Product Code:
Proprietary Name:
Dabigatran Etexilate
Non-Proprietary Name:
Dabigatran Etexilate
Substance Name:
Dabigatran Etexilate Mesylate
Usage Information:
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.
11-Digit NDC Billing Format:
00904725468
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
6 EA
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Major Pharmaceuticals
Dosage Form:
Capsule, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
ANDA208040
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-23-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 0904-7254-68?

The NDC Packaged Code 0904-7254-68 is assigned to a package of 6 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack (0904-7254-35) of Dabigatran Etexilate, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is capsule, coated pellets and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package.

Is NDC 0904-7254 included in the NDC Directory?

Yes, Dabigatran Etexilate with product code 0904-7254 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on June 23, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0904-7254-68?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 6.

What is the 11-digit format for NDC 0904-7254-68?

The 11-digit format is 00904725468. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20904-7254-685-4-200904-7254-68