DILANTIN
- Product NDC
- 58151-110
- 11-digit product format
- 581510110
- Labeler code
- 58151
- Product ID
- 58151-110_872f23a8-e6a3-4038-922d-0c26fc81d8b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Extended Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- ANDA084349
- Marketing category
- ANDA
- Marketing start
- 2024-12-06
- 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
- DILANTIN
- 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, 855673, 855869, 855871 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58151-110-01 | DILANTIN | 100 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 100 | | 3 |
| 58151-110-10 | DILANTIN | 1000 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 1000 | | 3 |
| 58151-110-32 | DILANTIN | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | | 3 |
| 58151-110-88 | DILANTIN | 100 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58151-110 | DILANTIN (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC] | 3 | Current NDC, 4 package rows | 20250410_86dd27d1-9cee-48ae-b55d-e2d2f7dbc593.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58151-110-01 | 58151011001 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01) | | 2024-12-06 | No | No | Current |
| 58151-110-10 | 58151011010 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10) | | 2025-04-09 | No | No | Current |
| 58151-110-32 | 58151011032 | 1 in 1 BLISTER PACK | | | | | Historical |
| 58151-110-88 | 58151011088 | 100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32) | 100 blister pack | 2024-12-06 | No | No | Current |