Phenytoin Sodium
- Product NDC
- 53002-2501
- 11-digit product format
- 530022501
- Labeler code
- 53002
- Product ID
- 53002-2501_d0035815-22ed-49cd-9f9e-d796bdac48a7
- 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
- 2006-09-05
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 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
- 2021-12-31
- 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 |
|---|
| 53002-2501-0 | 53002250100 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-2501-0) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-2501-3 | 53002250103 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-2501-3) | 2019-01-01 | 0000-00-00 | No | No | Current |