Search by Drug Name or NDC
NDC 63629-8529-01 Phenytoin Sodium 100 mg/1 Details
Phenytoin Sodium 100 mg/1
Phenytoin Sodium is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-8529-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenytoin
Product Information
| NDC | 63629-8529 |
|---|---|
| Product ID | 63629-8529_f16a94f8-6d0b-45a0-9e5a-40ba9bef08f5 |
| Associated GPIs | 72200030200110 |
| GCN Sequence Number | 004521 |
| GCN Sequence Number Description | phenytoin sodium extended CAPSULE 100 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 17700 |
| HICL Sequence Number | 001877 |
| HICL Sequence Number Description | PHENYTOIN SODIUM EXTENDED |
| Brand/Generic | Generic |
| Proprietary Name | Phenytoin Sodium |
| 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 | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | PHENYTOIN SODIUM |
| Labeler Name | Bryant Ranch Prepack |
| 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 | ANDA040684 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-8529-01 (63629852901)
| NDC Package Code | 63629-8529-1 |
|---|---|
| Billing NDC | 63629852901 |
| Package | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8529-1) |
| Marketing Start Date | 2017-07-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |