Prescription drug · ANDA
Dabigatran etexilate NDC 43598-453
Dabigatran etexilate mesylate 110 mg/1 · Capsule · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-453-60 | 4359804536043598045360 | 60 CAPSULE in 1 BOTTLE (43598-453-60)Marketed from Feb 28, 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 — 110 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories IncNDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208048
- Marketing start
- Listing expires
- Other FDA classes
- Thrombin Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-453_e9e8ec3b-2d7e-31cc-6268-60e4da2236baSPL ID e9e8ec3b-2d7e-31cc-6268-60e4da2236baSPL set ID a608e019-db9a-d6fb-cd0d-cecc1351a2b1RxCUI 1037045, 1037179, 1723476UNII SC7NUW5IITUPC 0343598641607, 0343598642604, 0343598453606
- 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
N443598045360followed by a unit qualifier and the quantityPackage 43598-0453-60. 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 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 b…
Excerpt only. Read the full label for complete information.
About NDC 43598-453
- What is NDC 43598-453?
- 43598-453 is the product NDC for Dabigatran etexilate, Dabigatran etexilate mesylate 110 mg/1 capsule, listed with the FDA by Dr.Reddys Laboratories Inc. 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?
- Dr.Reddys Laboratories Inc, NDC labeler code 43598. 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 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 208048
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 | Dr.Reddys Laboratories Inc | 43598-641 |
| Dabigatran etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-642 |