Prescription drug · NDA
Pradaxa (Dabigatran etexilate) NDC 0597-0435
Dabigatran etexilate mesylate 40 mg/1 · Pellet · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0435-96 | 0059704359600597043596 | 1 BAG in 1 CARTON (0597-0435-96) / 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 — 40 mg/1
- Dosage form
- Pellet
- Route
- Oral
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214358
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 0597-0435_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
N400597043596followed by a unit qualifier and the quantityPackage 00597-0435-96. 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 . 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.
About NDC 0597-0435
- What is NDC 0597-0435?
- 0597-0435 is the product NDC for Pradaxa (dabigatran etexilate), Dabigatran etexilate mesylate 40 mg/1 pellet, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pradaxa (Dabigatran etexilate).
- What is the active ingredient?
- Dabigatran etexilate mesylate.
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pradaxa?
- 8 other product NDCs are listed under this name. See all Pradaxa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pradaxa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 20 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0425 | 00597-0425-78 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 30 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0430 | 00597-0430-18 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 50 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0440 | 00597-0440-53 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 110 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0445 | 00597-0445-87 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0450 | 00597-0450-16 |
| Pradaxadabigatran etexilate mesylate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0360 | 00597-0360-5500597-0360-82 |
| Pradaxadabigatran etexilate mesylate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0108 | 00597-0108-5400597-0108-60 |
| Pradaxadabigatran etexilate mesylate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0355 | 00597-0355-0900597-0355-56 |
Other NDCs under NDA 214358
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 20 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0425 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 30 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0430 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 50 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0440 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 110 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0445 |
| Pradaxadabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | PelletOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0450 |