NDC product
Fosphenytoin sodium
NDC 68083-461 · Gland Pharma Limited
Key facts
| Product NDC | 68083-461 |
|---|---|
| Proprietary name | Fosphenytoin sodium |
| Nonproprietary name | Fosphenytoin sodium |
| Substances | FOSPHENYTOIN SODIUM |
| Dosage form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR, INTRAVENOUS |
| Labeler | Gland Pharma Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA214926 |
| Pharmacologic classes | Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA] and 3 more |
| Marketing start | Oct 13, 2023 |
| Listing certified through | Dec 31, 2026 |
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: