Fosphenytoin Sodium
- Product NDC
- 67457-516
- 11-digit product format
- 674570516
- Labeler code
- 67457
- Product ID
- 67457-516_6c9313b1-9247-4c40-b6aa-1ba1554b6c7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosphenytoin Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA078736
- Marketing category
- ANDA
- Marketing start
- 2016-12-06
- Marketing end
- 2022-12-31
- Substance
- FOSPHENYTOIN SODIUM
- Active strength
- 50 mg/mL
- Pharmacologic classes
- 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 P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-516-25 | 67457051625 | 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-516-25) > 2 mL in 1 VIAL, SINGLE-DOSE (67457-516-00) | 2016-12-06 | 2022-12-31 | No | No | Current |