Prescription drug · ANDA
Dabigatran (Dabigatran etexilate) NDC 50268-200
Dabigatran etexilate mesylate 150 mg/1 · Capsule · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-200-16 | 5026802001650268020016 | 60 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11)Marketed from Jul 12, 2025 |
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
- Generic name (nonproprietary)
- dabigatran etexilate
- Active ingredients
- Dabigatran etexilate mesylate — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213879
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9aSPL ID 43cbae6c-3c71-51aa-e063-6394a90a6d9aSPL set ID 39ac558a-b375-f3c1-e063-6394a90aa901RxCUI 1037045UNII 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
N450268020016followed by a unit qualifier and the quantityPackage 50268-0200-16. 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 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 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate ca…
Excerpt only. Read the full label for complete information.
About NDC 50268-200
- What is NDC 50268-200?
- 50268-200 is the product NDC for Dabigatran (dabigatran etexilate), Dabigatran etexilate mesylate 150 mg/1 capsule, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dabigatran (Dabigatran etexilate).
- What is the active ingredient?
- Dabigatran etexilate mesylate.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dabigatran?
- 9 other product NDCs are listed under this name. See all Dabigatran NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dabigatran products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | American Health Packaging | 60687-963 | 60687-0963-21 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | American Health Packaging | 60687-974 | 60687-0974-32 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | AvKARE | 42291-033 | 42291-0033-60 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | AvKARE | 42291-034 | 42291-0034-60 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-203 | 72205-0203-3472205-0203-60 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7530 | 50090-7530-00 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7531 | 50090-7531-00 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-202 | 72205-0202-3472205-0202-60 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-204 | 72205-0204-3472205-0204-60 |
Other NDCs under ANDA 213879
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 |
|---|---|---|---|---|
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | AvKARE | 42291-033 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | AvKARE | 42291-034 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7530 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7531 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | American Health Packaging | 60687-963 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | American Health Packaging | 60687-974 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-202 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-203 |
| Dabigatrandabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-204 |