Fosphenytoin Sodium
- Product NDC
- 70121-1381
- 11-digit product format
- 701211381
- Labeler code
- 70121
- Product ID
- 70121-1381_6a6abb75-fca4-400c-9ecb-073802e0cb7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosphenytoin
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078476
- Marketing category
- ANDA
- Marketing start
- 2016-08-11
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-1381 | FOSPHENYTOIN SODIUM (FOSPHENYTOIN) INJECTION [AMNEAL PHARMACEUTICALS LLC] | 20 | Legacy NDC | 20240806_39b58213-b9e2-4847-9010-99e187c1b778.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70121-1381-5 | 70121138105 | 25 VIAL in 1 CARTON (70121-1381-5) > 2 mL in 1 VIAL (70121-1381-1) | 25 vial | 2016-08-11 | 0000-00-00 | No | No | Current |