Dabigatran Etexilate NDC 0378-0266

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0266Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0266Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-0266-91	00378026691	60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91)Marketed from Feb 25, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Dabigatran Etexilate
Generic name (nonproprietary): dabigatran etexilate
Active ingredients: Dabigatran etexilate mesylate — 150 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208067
Marketing start: Feb 25, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 0378-0266_6c6b985e-111f-4fe9-a1ca-785c450e444bSPL ID 6c6b985e-111f-4fe9-a1ca-785c450e444bSPL set ID baafb5be-ffe6-4755-a7ab-817b3c9b222dRxCUI 1037045, 1037179UNII SC7NUW5IITUPC 0303780266933
Pharmacologic class: Direct Thrombin Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378026691 followed by a unit qualifier and the quantity

Package 00378-0266-91. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have bee…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208067

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208067
Product	Strength	Form · route	Labeler	Product NDC
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	0378-0265