Phenytoin Sodium is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Phenytoin Sodium.
| Product ID | 70518-1776_7eacd003-5bb9-c1e4-e053-2a91aa0a739a |
| NDC | 70518-1776 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Phenytoin Sodium |
| Generic Name | Phenytoin Sodium |
| Dosage Form | Capsule, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-01-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040684 |
| Labeler Name | REMEDYREPACK 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 | 2020-12-31 |
| Marketing Start Date | 2019-01-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040684 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-01-19 |
| Marketing Category | ANDA |
| Application Number | ANDA040684 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-01-03 |
| Marketing Category | ANDA |
| Application Number | ANDA040684 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-01-15 |
| Ingredient | Strength |
|---|---|
| PHENYTOIN SODIUM | 100 mg/1 |
| SPL SET ID: | c0946de1-2a2d-47ff-8071-50c1d3ad7982 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 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 |
| 29300-379 | Phenytoin Sodium | Phenytoin Sodium |
| 39822-4050 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 42192-614 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 70518-0107 | Phenytoin Sodium | Phenytoin Sodium |
| 70518-0981 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 70518-1776 | Phenytoin Sodium | Phenytoin Sodium |
| 71335-0913 | Phenytoin Sodium | Phenytoin Sodium |
| 71335-0232 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 50090-3499 | Phenytoin Sodium | Phenytoin Sodium |
| 50090-2903 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 50090-3539 | Phenytoin Sodium | Phenytoin Sodium |
| 51079-905 | Phenytoin Sodium | Phenytoin Sodium |
| 51662-1251 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 51662-1250 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 51672-4111 | Phenytoin Sodium | Phenytoin Sodium |
| 52584-555 | Phenytoin Sodium | Phenytoin Sodium |
| 52584-493 | Phenytoin Sodium | Phenytoin Sodium |
| 53002-1501 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 53808-0652 | Phenytoin Sodium | Phenytoin Sodium |
| 55154-5496 | Phenytoin Sodium | Phenytoin Sodium |
| 55154-5117 | Phenytoin Sodium | Phenytoin Sodium |
| 57664-808 | Phenytoin Sodium | Phenytoin Sodium |
| 58118-1402 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 58118-4111 | Phenytoin Sodium | Phenytoin Sodium |
| 61919-815 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 62756-299 | phenytoin sodium | phenytoin sodium |
| 62756-402 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 62756-432 | phenytoin sodium | phenytoin sodium |
| 63187-891 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 63629-6382 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 63629-6364 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 63629-2552 | Phenytoin Sodium | Phenytoin Sodium |
| 64725-4111 | Phenytoin Sodium | Phenytoin Sodium |
| 67046-585 | Phenytoin Sodium | Phenytoin Sodium |
| 67296-1251 | PHENYTOIN SODIUM | PHENYTOIN SODIUM |
| 67544-517 | Phenytoin Sodium | Phenytoin Sodium |
| 0071-0369 | Dilantin | Phenytoin Sodium |
| 0071-3740 | Dilantin | Phenytoin Sodium |
| 43353-131 | Dilantin | Phenytoin Sodium |
| 0904-6187 | Extended Phenytoin Sodium | Phenytoin Sodium |