Dabigatran Etexilate NDC 72603-239

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-239Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0239Add 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
72603-239-01	72603023901	60 CAPSULE in 1 BOTTLE (72603-239-01)Marketed from Dec 1, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: NorthStar RxLLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207961
Marketing start: Dec 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 72603-239_450cc975-a89f-2a41-e063-6394a90aefcfSPL ID 450cc975-a89f-2a41-e063-6394a90aefcfSPL set ID d5937f27-88c7-4c4a-801e-4c8945008982RxCUI 1037045UNII SC7NUW5IITUPC 0372603239010
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

N472603023901 followed by a unit qualifier and the quantity

Package 72603-0239-01. 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 Dec 3, 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 to 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207961

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

FDA NDC Directory listings under ANDA 207961
Product	Strength	Form · route	Labeler	Product NDC
Dabigatran Etexilate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-622
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-621
Dabigatran Etexilate	Dabigatran etexilate mesylate 110 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-666
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	XLCare Pharmaceuticals, Inc.	72865-272
Dabigatran Etexilate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	XLCare Pharmaceuticals, Inc.	72865-273