Fosphenytoin Sodium
- Product NDC
- 25021-798
- 11-digit product format
- 250210798
- Labeler code
- 25021
- Product ID
- 25021-798_20212ecb-248d-4fc6-b88d-c54a18076845
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosphenytoin Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA214926
- Marketing category
- ANDA
- Marketing start
- 2025-01-15
- Substance
- FOSPHENYTOIN SODIUM
- Active strength
- 50 mg/mL
- 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], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7VLR55452Z | FOSPHENYTOIN SODIUM | 92134-98-0 | FOSPHENYTOIN SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-798-02 | 25021079802 | 25 VIAL in 1 CARTON (25021-798-02) / 2 mL in 1 VIAL | 25 vial | 2025-01-15 | No | No | Historical |
| 25021-798-10 | 25021079810 | 10 VIAL in 1 CARTON (25021-798-10) / 10 mL in 1 VIAL | 10 vial | 2025-01-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fosphenytoin Sodium | Sagent Pharmaceuticals | 2024-12-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |