Phenytek
- Product NDC
- 67046-1486
- 11-digit product format
- 670461486
- Labeler code
- 67046
- Product ID
- 67046-1486_2cdc1905-8ef2-1275-e063-6394a90a2ab7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- extended phenytoin sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA040298
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- Substance
- PHENYTOIN SODIUM
- Active strength
- 200 mg/1
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1486-3 | 67046148603 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3) | 2025-01-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Phenytek | Coupler LLC | 2025-01-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |