Pradaxa (dabigatran etexilate mesylate) NDC 0597-0108

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0108Add 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
0597-0108-54	00597010854	1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLEMarketed from Jul 7, 2017
0597-0108-60	00597010860	10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACKMarketed from Nov 23, 2015

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): Pradaxa
Generic name (nonproprietary): dabigatran etexilate mesylate
Active ingredients: Dabigatran etexilate mesylate — 110 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022512
Marketing start: Nov 23, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 0597-0108_ecf1aa06-c610-4fdb-a380-2e716d7e63c2SPL ID ecf1aa06-c610-4fdb-a380-2e716d7e63c2SPL set ID ba74e3cd-b06f-4145-b284-5fd6b84ff3c9RxCUI 1037045, 1037049, 1037179, 1037181, 1723476, 1723478UNII SC7NUW5IIT
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

N400597010854 followed by a unit qualifier and the quantity

Package 00597-0108-54. 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 Jun 25, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

PRADAXA Capsules is 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 been treated with a parente…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022512

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

FDA NDC Directory listings under NDA 022512
Product	Strength	Form · route	Labeler	Product NDC
Pradaxadabigatran etexilate mesylate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	Boehringer Ingelheim Pharmaceuticals Inc.	0597-0355
Pradaxadabigatran etexilate mesylate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	Boehringer Ingelheim Pharmaceuticals Inc.	0597-0360