DILANTIN
- Product NDC
- 70518-4325
- 11-digit product format
- 705184325
- Labeler code
- 70518
- Product ID
- 70518-4325_402f06b8-06fa-e2d6-e063-6294a90ad8c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Extended Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA084349
- Marketing category
- ANDA
- Marketing start
- 2025-04-02
- Substance
- PHENYTOIN SODIUM
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4182431BJH |
| Rxcui | 855869, 855871 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4325-0 | DILANTIN | 100 in 1 BOX | CAPSULE, EXTENDED RELEASE | 100 | | 2 |
| 70518-4325-1 | DILANTIN | 1 in 1 POUCH | CAPSULE, EXTENDED RELEASE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4325 | DILANTIN (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250406_db8c69b0-4697-433e-98c7-b0b2d2c52a83.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 |
|---|
| 70518-4325-0 | 70518432500 | 100 POUCH in 1 BOX (70518-4325-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1) | 100 pouch | 2025-04-02 | No | No | Historical |
| 70518-4325-1 | 70518432501 | 1 in 1 POUCH | | | | | Historical |