NDC product
Nicotine Polacrilex Gum
NDC 63443-5057 · Fertin Pharma A/S
Key facts
| Product NDC | 63443-5057 |
|---|---|
| Proprietary name | Nicotine Polacrilex Gum |
| Nonproprietary name | Nicotine Polacrilex |
| Substances | NICOTINE |
| Dosage form | GUM, CHEWING |
| Route | BUCCAL |
| Labeler | Fertin Pharma A/S |
| Product type | HUMAN OTC DRUG |
| Marketing category | ANDA |
| Application number | ANDA214354 |
| Pharmacologic classes | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| Marketing start | Dec 21, 2022 |
| 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: