PHENYTOIN SODIUM
- Product NDC
- 0404-9808
- 11-digit product format
- 004049808
- Labeler code
- 0404
- Product ID
- 0404-9808_5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phenytoin sodium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA084307
- Marketing category
- ANDA
- Marketing start
- 2024-12-26
- Substance
- PHENYTOIN 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 |
|---|
| 4182431BJH | PHENYTOIN SODIUM | 630-93-3 | PHENYTOIN SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9808-05 | 00404980805 | 1 VIAL in 1 BAG (0404-9808-05) / 5 mL in 1 VIAL | 1 vial | 2024-12-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| PHENYTOIN SODIUM | Henry Schein, Inc. | 2024-12-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |