NDC 43353-131
Dilantin
Phenytoin Sodium
Dilantin is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Inc.. The primary component is Phenytoin Sodium.
| Product ID | 43353-131_0bedfead-19aa-4149-ba58-4d0f189267b7 |
| NDC | 43353-131 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dilantin |
| Generic Name | Phenytoin Sodium |
| Dosage Form | Capsule, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 1976-08-27 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA084349 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, Inc. |
| Substance Name | PHENYTOIN SODIUM |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 43353-131-70
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-131-70)
| Marketing Start Date | 1976-08-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 43353-131-60 [43353013160]
Dilantin CAPSULE, EXTENDED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA084349 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1976-08-27 |
| Inactivation Date | 2020-01-31 |
NDC 43353-131-92 [43353013192]
Dilantin CAPSULE, EXTENDED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA084349 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1976-08-27 |
| Inactivation Date | 2020-01-31 |
NDC 43353-131-75 [43353013175]
Dilantin CAPSULE, EXTENDED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA084349 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1976-08-27 |
| Inactivation Date | 2020-01-31 |
NDC 43353-131-94 [43353013194]
Dilantin CAPSULE, EXTENDED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA084349 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1976-08-27 |
| Inactivation Date | 2020-01-31 |
NDC 43353-131-70 [43353013170]
Dilantin CAPSULE, EXTENDED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA084349 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1976-08-27 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PHENYTOIN SODIUM | 100 mg/1 |
OpenFDA Data
| SPL SET ID: | ecab970d-83e9-4aad-92de-dbb73d7a151f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Anti-epileptic Agent [EPC]
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Cytochrome P450 1A2 Inducers [MoA]
- Cytochrome P450 2B6 Inducers [MoA]
- Cytochrome P450 2C8 Inducers [MoA]
- Cytochrome P450 2C19 Inducers [MoA]
- Cytochrome P450 2D6 Inducers [MoA]
- Cytochrome P450 3A Inducers [MoA]
- Cytochrome P450 2C9 Inducers [MoA]
NDC Crossover Matching brand name "Dilantin" or generic name "Phenytoin Sodium"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0071-0369 | Dilantin | Extended Phenytoin Sodium |
| 0071-3740 | Dilantin | Extended Phenytoin Sodium |
| 68151-1019 | Dilantin | Dilantin |
| 69189-3742 | Dilantin | Dilantin |
| 70518-0980 | Dilantin | Dilantin |
| 43353-131 | Dilantin | Dilantin |
| 50090-0029 | Dilantin | Dilantin |
| 0904-6187 | Extended Phenytoin Sodium | Phenytoin Sodium |
| 10135-603 | Extended Phenytoin Sodium | Phenytoin Sodium |
| 0378-3750 | Phenytek | phenytoin sodium |
| 0378-1560 | Phenytoin Sodium | phenytoin sodium |
| 0404-9932 | Phenytoin Sodium | Phenytoin Sodium |
| 0404-9933 | Phenytoin Sodium | Phenytoin Sodium |
| 0615-1343 | Phenytoin Sodium | phenytoin sodium |
| 0615-8020 | Phenytoin Sodium | Phenytoin Sodium |
| 0641-0493 | Phenytoin Sodium | Phenytoin Sodium |
| 0641-2555 | Phenytoin Sodium | Phenytoin Sodium |
| 0641-6138 | Phenytoin Sodium | Phenytoin Sodium |
| 0641-6139 | Phenytoin Sodium | Phenytoin Sodium |
| 21695-167 | Phenytoin Sodium | Phenytoin Sodium |
Trademark Results [Dilantin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DILANTIN 71404865 0359292 Live/Registered |
PARKE, DAVIS & COMPANY 1938-04-04 |
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