Phenytoin Sodium
- Product NDC
- 70518-1776
- 11-digit product format
- 705181776
- Labeler code
- 70518
- Product ID
- 70518-1776_d9f5349f-838c-51ac-e053-2995a90af70e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2019-01-03
- 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 |
|---|
| 70518-1776 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] | 11 | Legacy NDC | 20250228_c0946de1-2a2d-47ff-8071-50c1d3ad7982.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1776-0 | 70518177600 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-1776-0) | | 2019-01-03 | 0000-00-00 | No | No | Current |
| 70518-1776-1 | 70518177601 | 100 POUCH in 1 BOX (70518-1776-1) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-1776-2) | 100 pouch | 2020-01-15 | 0000-00-00 | No | No | Current |