Prescription drug · ANDA
Dabigatran Etexilate NDC 50090-7656
Dabigatran etexilate mesylate 75 mg/1 · Capsule, Coated pellets · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7656-0 | 5009076560050090765600 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-7656-0)Marketed from Sep 18, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-7656_c9ac120f-f8a2-4be5-9060-4f90a2e1ef10SPL ID c9ac120f-f8a2-4be5-9060-4f90a2e1ef10SPL set ID b31d27e9-5502-43c5-83fa-89608c014b7aRxCUI 1037179UNII 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
N450090765600followed by a unit qualifier and the quantityPackage 50090-7656-00. 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 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran Etexilate …
Excerpt only. Read the full label for complete information.
About NDC 50090-7656
- What is NDC 50090-7656?
- 50090-7656 is the product NDC for Dabigatran Etexilate, Dabigatran etexilate mesylate 75 mg/1 capsule, coated pellets, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dabigatran Etexilate.
- What is the active ingredient?
- Dabigatran etexilate mesylate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 Etexilate?
- 30 other product NDCs are listed under this name. See all Dabigatran Etexilate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dabigatran Etexilate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-239 | 72603-0239-01 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-624 | 67877-0624-3167877-0624-60 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 75 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7253 | 00904-7253-0400904-7253-68 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7254 | 00904-7254-68 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7255 | 00904-7255-1000904-7255-68 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-973 | 59651-0973-6059651-0973-61 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-974 | 59651-0974-6059651-0974-61 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-975 | 59651-0975-6059651-0975-61 |
| Dabigatran etexilate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-453 | 43598-0453-60 |
| Dabigatran etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-641 | 43598-0641-60 |
Other NDCs under ANDA 208040
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 75 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7253 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7254 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | Capsule, Coated pelletsOral | Major Pharmaceuticals | 0904-7255 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | Capsule, Coated pelletsOral | A-S Medication Solutions | 50090-7657 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 75 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-474 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-475 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-624 |