Fosphenytoin Sodium is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Fosphenytoin Sodium.
| Product ID | 0143-9788_6b56fe59-9fb1-410b-b57c-7ada1662136a |
| NDC | 0143-9788 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fosphenytoin Sodium |
| Generic Name | Fosphenytoin Sodium |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAMUSCULAR; INTRAVENOUS |
| Marketing Start Date | 2009-12-02 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078765 |
| Labeler Name | West-Ward Pharmaceuticals Corp |
| Substance Name | FOSPHENYTOIN SODIUM |
| Active Ingredient Strength | 50 mg/mL |
| Pharm Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2009-12-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078765 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-10-27 |
| Marketing Category | ANDA |
| Application Number | ANDA078765 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-02 |
| Ingredient | Strength |
|---|---|
| FOSPHENYTOIN SODIUM | 50 mg/mL |
| SPL SET ID: | c92df63b-5140-4213-8d43-8327ff6230b7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9782 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 0143-9788 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 0641-6136 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 0641-6137 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 64679-729 | FOSPHENYTOIN SODIUM | fosphenytoin sodium |
| 64679-730 | FOSPHENYTOIN SODIUM | fosphenytoin sodium |
| 65162-998 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 70121-1381 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 70121-1390 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 65162-999 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium |
| 0069-5471 | CEREBYX | Fosphenytoin Sodium |
| 0069-5474 | CEREBYX | Fosphenytoin Sodium |
| 0069-6001 | CEREBYX | Fosphenytoin Sodium |
| 63323-403 | Fosphenytoin | FOSPHENYTOIN SODIUM |