Phenytoin
- Product NDC
- 0378-3850
- 11-digit product format
- 003783850
- Labeler code
- 0378
- Product ID
- 0378-3850_27a1d06e-f2f6-4219-b0e8-2af628ba62f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA200691
- Marketing category
- ANDA
- Marketing start
- 2012-12-26
- Marketing end
- 2022-02-28
- Substance
- PHENYTOIN
- Active strength
- 50 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
- 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 |
|---|
| 0378-3850-01 | 00378385001 | 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-01) | 2012-12-26 | 2022-02-28 | No | No | Current |
| 0378-3850-05 | 00378385005 | 500 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-05) | 2012-12-26 | 0000-00-00 | No | No | Current |