Phenytoin Sodium
- Product NDC
- 71335-0913
- 11-digit product format
- 713350913
- Labeler code
- 71335
- Product ID
- 71335-0913_f7e83c80-a372-4704-9faa-18d66454f03d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-0913-1 | 71335091301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-1) | 2022-09-19 | 0000-00-00 | No | No | Current |
| 71335-0913-2 | 71335091302 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-2) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-0913-3 | 71335091303 | 180 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-3) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-0913-4 | 71335091304 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-4) | 2017-07-24 | 0000-00-00 | No | No | Current |
| 71335-0913-5 | 71335091305 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-5) | 2017-07-24 | 0000-00-00 | No | No | Current |
| 71335-0913-6 | 71335091306 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-6) | 2017-07-24 | 0000-00-00 | No | No | Current |
| 71335-0913-7 | 71335091307 | 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0913-7) | 2022-02-14 | 0000-00-00 | No | No | Current |