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 | 59651097560 | 60 CAPSULE in 1 BOTTLE (59651-975-60)Marketed from May 14, 2025 | |
| 59651-975-61 | 59651097561 | 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 Limited
- 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.