Phenytoin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Phenytoin.
| Product ID | 70518-1967_848f5071-6c3b-6eb0-e053-2a91aa0a9b99 |
| NDC | 70518-1967 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Phenytoin |
| Generic Name | Phenytoin |
| Dosage Form | Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-03-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040521 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | PHENYTOIN |
| Active Ingredient Strength | 125 mg/5mL |
| 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 | 2019-03-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040521 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-20 |
| Marketing Category | ANDA |
| Application Number | ANDA040521 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-20 |
| Ingredient | Strength |
|---|---|
| PHENYTOIN | 125 mg/5mL |
| SPL SET ID: | 3cac9830-f71e-4111-b116-47f23077c21d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0121-0892 | Phenytoin | Phenytoin |
| 0378-3850 | Phenytoin | Phenytoin |
| 0615-7764 | Phenytoin | Phenytoin |
| 0904-7079 | Phenytoin | Phenytoin |
| 0904-7199 | Phenytoin | Phenytoin |
| 17856-0067 | Phenytoin | Phenytoin |
| 17856-4069 | Phenytoin | Phenytoin |
| 17856-4070 | Phenytoin | Phenytoin |
| 51079-129 | Phenytoin | Phenytoin |
| 51672-4069 | Phenytoin | Phenytoin |
| 51672-4146 | Phenytoin | Phenytoin |
| 59762-0531 | Phenytoin | Phenytoin |
| 70518-0841 | Phenytoin | Phenytoin |
| 70518-1967 | Phenytoin | Phenytoin |
| 60432-131 | Phenytoin | Phenytoin |
| 60687-156 | Phenytoin | Phenytoin |
| 60687-275 | Phenytoin | Phenytoin |
| 64950-231 | Phenytoin | Phenytoin |
| 66689-775 | Phenytoin | Phenytoin |
| 66689-036 | Phenytoin | Phenytoin |
| 70518-2554 | Phenytoin | Phenytoin |
| 0071-0007 | Dilantin Infatabs | Phenytoin |
| 0071-2214 | Dilantin-125 | Phenytoin |
| 0615-8260 | Phenytoin Infatabs | Phenytoin |
| 0615-8424 | Phenytoin Infatabs | Phenytoin |