Extended Phenytoin Sodium
- Product NDC
- 0615-8556
- 11-digit product format
- 006158556
- Labeler code
- 0615
- Product ID
- 0615-8556_8240390a-9bc8-4256-8f2a-107c97c0400c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA204309
- Marketing category
- ANDA
- Marketing start
- 2015-06-10
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8556-39 | 00615855639 | 30 CAPSULE in 1 BLISTER PACK (0615-8556-39) | 30 capsule | 2024-10-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Extended Phenytoin Sodium | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-10-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |