Prescription drug · ANDA
Dabigatran Etexilate NDC 0904-7253
Dabigatran etexilate mesylate 75 mg/1 · Capsule, Coated pellets · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7253-04 | 00904725304 | 3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)Marketed from Jun 23, 2025 | |
| 0904-7253-68 | 00904725368 | 6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)Marketed from Jun 23, 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 — 75 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208040
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-7253_869fd2f3-9357-4148-8b64-0cca96dd5f75SPL ID 869fd2f3-9357-4148-8b64-0cca96dd5f75SPL set ID b76b79ce-b7dd-4390-b40e-71ae6c477d10RxCUI 1037045, 1037179, 1723476UNII SC7NUW5IITUPC 0309047253043, 0309047255108
- 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
N400904725304followed by a unit qualifier and the quantityPackage 00904-7253-04. 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)
Dabigatran Etexilate 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 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 been treate…
Excerpt only. Read the full label for complete information.