Phenytoin Infatabs
- Product NDC
- 0615-8260
- 11-digit product format
- 006158260
- Labeler code
- 0615
- Product ID
- 0615-8260_38d6f9ab-c76b-4d2c-94f9-c76cafa98fbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA084427
- Marketing category
- ANDA
- Marketing start
- 2012-12-27
- Marketing end
- 2023-11-30
- Substance
- PHENYTOIN
- Active strength
- 50 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8260-39 | 00615826039 | 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8260-39) | 2019-01-08 | 2023-11-30 | No | No | Current |