Phenytoin
- Product NDC
- 0904-7079
- 11-digit product format
- 009047079
- Labeler code
- 0904
- Product ID
- 0904-7079_070e56f4-db77-4ead-aad9-054a1dad8507
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA040521
- Marketing category
- ANDA
- Marketing start
- 2004-04-08
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN
- Active strength
- 100 mg/4mL
- 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
- 2023-12-31
- 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 |
|---|
| 0904-7079-57 | 00904707957 | 50 CUP, UNIT-DOSE in 1 CASE (0904-7079-57) > 4 mL in 1 CUP, UNIT-DOSE (0904-7079-24) | 2004-04-08 | 0000-00-00 | No | No | Current |