NDC product
Dabigatran Etexilate
NDC 0378-0265 · Mylan Pharmaceuticals Inc.
Key facts
| Product NDC | 0378-0265 |
|---|---|
| Proprietary name | Dabigatran Etexilate |
| Nonproprietary name | Dabigatran Etexilate |
| Substances | DABIGATRAN ETEXILATE MESYLATE |
| Dosage form | CAPSULE |
| Route | ORAL |
| Labeler | Mylan Pharmaceuticals Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA208067 |
| Pharmacologic classes | Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| Marketing start | Feb 25, 2025 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: