Prescription drug · ANDA
Dabigatran Etexilate NDC 72865-272
Dabigatran etexilate mesylate 75 mg/1 · Capsule · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-272-60 | 72865027260 | 60 CAPSULE in 1 BOTTLE (72865-272-60)Marketed from Aug 1, 2023 |
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 — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207961
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 72865-272_3f2f2d85-443a-46a1-a637-69b106156df4SPL ID 3f2f2d85-443a-46a1-a637-69b106156df4SPL set ID 19b3bfc1-4fcb-4eb9-a611-02c27c05c56eRxCUI 1037045, 1037179UNII SC7NUW5IITUPC 0372865272602, 0372865273609
- 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
N472865027260followed by a unit qualifier and the quantityPackage 72865-0272-60. 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 are direct thrombin inhibitors 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 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-va…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207961
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 |
|---|---|---|---|---|
| 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 150 mg/1 | CapsuleOral | XLCare Pharmaceuticals, Inc. | 72865-273 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-239 |