Pradaxa (dabigatran etexilate) NDC 0597-0445

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0445Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0445Add 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
0597-0445-87	00597044587	1 BAG in 1 CARTON (0597-0445-87) / 60 PELLET in 1 BAGMarketed from Mar 16, 2022

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
Active ingredients: Dabigatran etexilate mesylate — 110 mg/1
Dosage form: Pellet
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214358
Marketing start: Mar 16, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 0597-0445_56b1a7c2-0afd-40c6-bda5-563e234a9f28SPL ID 56b1a7c2-0afd-40c6-bda5-563e234a9f28SPL set ID 9ac0a64a-8666-45f7-9d4f-40fd894f7e6dRxCUI 2590616, 2590619, 2590620, 2590621, 2590623, 2590625, 2590627, 2590629, 2590631, 2590633, 2590635, 2590637UNII 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

N400597044587 followed by a unit qualifier and the quantity

Package 00597-0445-87. 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 27, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.1 ) To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated ( 1.2 ) 1.1 Treatment of Venous Thromboembolic Events in Pediatric Patients PRADAXA Oral Pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at le…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)