Phenytoin Sodium
- Product NDC
- 0904-7416
- 11-digit product format
- 009047416
- Labeler code
- 0904
- Product ID
- 0904-7416_46d5c0d1-a97b-46d9-8cf4-994780673337
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2025-12-09
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenytoin Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYTOIN SODIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4182431BJH |
| Rxcui | 855671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7416-61 | Phenytoin Sodium | 100 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 100 | | 1 |
| 0904-7416-61 | Phenytoin Sodium | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7416-61 | 00904741661 | 100 BLISTER PACK in 1 CARTON (0904-7416-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2025-12-09 | No | No | Historical |