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NDC 63323-0403-10 Fosphenytoin 50 mg/mL Details
Fosphenytoin 50 mg/mL
Fosphenytoin is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is FOSPHENYTOIN SODIUM.
MedlinePlus Drug Summary
Fosphenytoin 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. Fosphenytoin injection may also be used to control certain type of seizures in people who cannot take oral phenytoin. Fosphenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 63323-0403-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fosphenytoin Injection
Product Information
| NDC | 63323-0403 |
|---|---|
| Product ID | 63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3 |
| Associated GPIs | 72200013102024 72200013102028 |
| GCN Sequence Number | 063663 |
| GCN Sequence Number Description | fosphenytoin sodium VIAL 100MG PE/2 INJECTION |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 99384 |
| HICL Sequence Number | 011679 |
| HICL Sequence Number Description | FOSPHENYTOIN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Fosphenytoin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | FOSPHENYTOIN SODIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | FOSPHENYTOIN SODIUM |
| Labeler Name | Fresenius Kabi USA, 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 | ANDA078052 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0403-10 (63323040310)
| NDC Package Code | 63323-403-10 |
|---|---|
| Billing NDC | 63323040310 |
| Package | 10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04) |
| Marketing Start Date | 2009-12-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |