NDC product
Telmisartan and Amlodipine
NDC 0378-1075 · Mylan Pharmaceuticals Inc.
Key facts
| Product NDC | 0378-1075 |
|---|---|
| Proprietary name | Telmisartan and Amlodipine |
| Nonproprietary name | telmisartan and amlodipine |
| Substances | TELMISARTAN, AMLODIPINE BESYLATE |
| Dosage form | TABLET |
| Route | ORAL |
| Labeler | Mylan Pharmaceuticals Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA202516 |
| Pharmacologic classes | Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC] and 1 more |
| Marketing start | Sep 19, 2014 |
| 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: