Extended Phenytoin Sodium
- Product NDC
- 42291-772
- 11-digit product format
- 422910772
- Labeler code
- 42291
- Product ID
- 42291-772_d5c99427-ea90-47d7-e053-2a95a90a9384
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA040765
- Marketing category
- ANDA
- Marketing start
- 2020-08-25
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-772 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AVKARE] | 4 | Legacy NDC | 20250215_adb76639-200b-7754-e053-2995a90ae398.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-772-01 | 42291077201 | 100 CAPSULE in 1 BOTTLE (42291-772-01) | 100 capsule | 2020-08-25 | 0000-00-00 | No | No | Current |
| 42291-772-10 | 42291077210 | 1000 CAPSULE in 1 BOTTLE (42291-772-10) | 1000 capsule | 2020-08-25 | 0000-00-00 | No | No | Current |