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NDC 00378-3750-93 Phenytek 300 mg/1 Details
Phenytek 300 mg/1
Phenytek is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is PHENYTOIN SODIUM.
MedlinePlus Drug Summary
Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 00378-3750-93Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenytoin
Product Information
| NDC | 00378-3750 |
|---|---|
| Product ID | 0378-3750_ef0ae0b6-fe8b-4aa7-bd37-5414db9069cf |
| Associated GPIs | 72200030200130 |
| GCN Sequence Number | 049444 |
| GCN Sequence Number Description | phenytoin sodium extended CAPSULE 300 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 15037 |
| HICL Sequence Number | 001877 |
| HICL Sequence Number Description | PHENYTOIN SODIUM EXTENDED |
| Brand/Generic | Brand |
| Proprietary Name | Phenytek |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | phenytoin sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | PHENYTOIN SODIUM |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | 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 |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040298 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-3750-93 (00378375093)
| NDC Package Code | 0378-3750-93 |
|---|---|
| Billing NDC | 00378375093 |
| Package | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93) |
| Marketing Start Date | 2001-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |