Search by Drug Name or NDC
NDC 42192-0614-06 PHENYTOIN SODIUM 50 mg/mL Details
PHENYTOIN SODIUM 50 mg/mL
PHENYTOIN SODIUM is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is PHENYTOIN SODIUM.
MedlinePlus Drug Summary
Phenytoin injection is used to treat primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin injection may also be used to control certain types of seizures in people who cannot take oral phenytoin. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 42192-0614-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenytoin Injection
Product Information
| NDC | 42192-0614 |
|---|---|
| Product ID | 42192-614_a6e2c6d9-fd28-4276-a578-976aba15cbf0 |
| Associated GPIs | 72200030052005 |
| GCN Sequence Number | 004528 |
| GCN Sequence Number Description | phenytoin sodium VIAL 50 MG/ML INTRAVEN |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 17200 |
| HICL Sequence Number | 001878 |
| HICL Sequence Number Description | PHENYTOIN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | PHENYTOIN SODIUM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PHENYTOIN SODIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | PHENYTOIN SODIUM |
| Labeler Name | Acella Pharmaceuticals, LLC |
| 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 | ANDA040573 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42192-0614-06 (42192061406)
| NDC Package Code | 42192-614-06 |
|---|---|
| Billing NDC | 42192061406 |
| Package | 25 VIAL in 1 CARTON (42192-614-06) / 5 mL in 1 VIAL |
| Marketing Start Date | 2021-12-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |