Phenytoin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Pai Holdings, Llc. The primary component is Phenytoin.
Product ID | 0121-0892_598abf5c-cda1-4f2b-80a6-08244044c5ee |
NDC | 0121-0892 |
Product Type | Human Prescription Drug |
Proprietary Name | Phenytoin |
Generic Name | Phenytoin |
Dosage Form | Suspension |
Route of Administration | ORAL |
Marketing Start Date | 2004-04-08 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA040521 |
Labeler Name | PAI Holdings, LLC |
Substance Name | PHENYTOIN |
Active Ingredient Strength | 125 mg/5mL |
Pharm 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 | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2020-03-26 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA040521 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2004-04-08 |
Marketing Category | ANDA |
Application Number | ANDA040521 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2020-03-26 |
Ingredient | Strength |
---|---|
PHENYTOIN | 125 mg/5mL |
SPL SET ID: | f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15 |
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 |