Phenytoin Sodium
- Product NDC
- 71610-869
- 11-digit product format
- 716100869
- Labeler code
- 71610
- Product ID
- 71610-869_29b8a9bb-8e99-a599-e063-6394a90ab307
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2006-09-05
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 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 |
|---|
| 71610-869-92 | 71610086992 | 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-92) | 2024-12-11 | No | No | Historical |
| 71610-869-94 | 71610086994 | 360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-94) | 2024-12-11 | No | No | Historical |
| 71610-869-98 | 71610086998 | 540 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-869-98) | 2024-12-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Phenytoin Sodium | Aphena Pharma Solutions - Tennessee, LLC | 2024-12-20 | HUMAN PRESCRIPTION DRUG LABEL | 1 |