Prescription drug · ANDA
Dabigatran Etexilate NDC 59651-975
Dabigatran etexilate mesylate 150 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-975-60 | 5965109756059651097560 | 60 CAPSULE in 1 BOTTLE (59651-975-60)Marketed from May 14, 2025 | |
| 59651-975-61 | 5965109756159651097561 | 10 BLISTER PACK in 1 CARTON (59651-975-61) / 6 CAPSULE in 1 BLISTER PACKMarketed from May 14, 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 Etexilate
- Generic name (nonproprietary)
- dabigatran etexilate
- Active ingredients
- Dabigatran etexilate mesylate — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208039
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-975_4b36f34b-c19b-497d-9dd6-5c50404226c5SPL ID 4b36f34b-c19b-497d-9dd6-5c50404226c5SPL set ID 5b196b1f-408e-4615-b980-9f822adff835RxCUI 1037045, 1037179, 1723476UNII SC7NUW5IITUPC 0359651974605
- 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
N459651097560followed by a unit qualifier and the quantityPackage 59651-0975-60. 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 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 treat…
Excerpt only. Read the full label for complete information.
About NDC 59651-975
- What is NDC 59651-975?
- 59651-975 is the product NDC for Dabigatran Etexilate, Dabigatran etexilate mesylate 150 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 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 |
| Dabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-642 | 43598-0642-60 |
Other NDCs under ANDA 208039
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 | CapsuleOral | Aurobindo Pharma Limited | 59651-973 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-974 |