PHENYTOIN SODIUM
- Product NDC
- 63187-891
- 11-digit product format
- 631870891
- Labeler code
- 63187
- Product ID
- 63187-891_29553798-cdb4-4f5a-99d5-be83f704559b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENYTOIN SODIUM
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040621
- Marketing category
- ANDA
- Marketing start
- 2006-12-12
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-891 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | Legacy NDC | 20191108_15e951c3-669d-4db0-8b7c-22c63b3e9af4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-891-30 | 63187089130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-30) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-891-60 | 63187089160 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-60) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-891-90 | 63187089190 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-891-90) | 2017-08-01 | 0000-00-00 | No | No | Current |