Extended Phenytoin Sodium
- Product NDC
- 70518-2227
- 11-digit product format
- 705182227
- Labeler code
- 70518
- Product ID
- 70518-2227_dafbca02-f4e8-e19e-e053-2995a90acee1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204309
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- 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 Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2227 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [REMEDYREPACK INC.] | 13 | Legacy NDC | 20250309_363cd347-d25e-42b9-9ce7-30642f3cb353.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2227-0 | 70518222700 | 30 CAPSULE in 1 BLISTER PACK (70518-2227-0) | 30 capsule | 2019-07-19 | 0000-00-00 | No | No | Current |