Phenytoin
- Product NDC
- 70518-3353
- 11-digit product format
- 705183353
- Labeler code
- 70518
- Product ID
- 70518-3353_d7c41fd6-e171-85f8-e053-2995a90a2d35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040610
- Marketing category
- ANDA
- Marketing start
- 2022-02-01
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN
- Active strength
- 125 mg/5mL
- 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 |
|---|
| 70518-3353-0 | 70518335300 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3353-0) > 1 mL in 1 CUP, UNIT-DOSE (70518-3353-1) | 2022-02-01 | 0000-00-00 | No | No | Current |