Phenytoin Sodium
- Product NDC
- 53002-4501
- 11-digit product format
- 530024501
- Labeler code
- 53002
- Product ID
- 53002-4501_a472ecd0-5e15-482a-bc98-9e8ae90b502f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2017-07-24
- Marketing end
- 0000-00-00
- 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
- 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 |
|---|
| 53002-4501-0 | 53002450100 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-4501-0) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-4501-3 | 53002450103 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-4501-3) | 2021-01-01 | 0000-00-00 | No | No | Current |