NDC product
Varenicline
NDC 10135-809 · Marlex Pharmaceuticals, Inc.
Key facts
| Product NDC | 10135-809 |
|---|---|
| Proprietary name | Varenicline |
| Nonproprietary name | Varenicline tartrate |
| Substances | VARENICLINE TARTRATE |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Labeler | Marlex Pharmaceuticals, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA217283 |
| Pharmacologic classes | Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA] |
| Marketing start | Jan 1, 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: