Fosphenytoin
- Product NDC
- 63323-403
- 11-digit product format
- 633230403
- Labeler code
- 63323
- Product ID
- 63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FOSPHENYTOIN SODIUM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA078052
- Marketing category
- ANDA
- Marketing start
- 2009-12-14
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosphenytoin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSPHENYTOIN SODIUM | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7VLR55452Z |
| Rxcui | 1670195, 1670200 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-403-01 | Fosphenytoin | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 14 |
| 63323-403-02 | Fosphenytoin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 14 |
| 63323-403-04 | Fosphenytoin | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 14 |
| 63323-403-10 | Fosphenytoin | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FOSPHENYTOIN SODIUM | ACTIVE INGREDIENT | 7VLR55452Z | FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-403 | FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 14 | Current NDC, Legacy NDC, 4 package rows | 20230519_b60c9c82-e5c7-4e05-98c7-5bbba4af04b2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-403-01 | 63323040301 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 63323-403-02 | 63323040302 | 25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01) | 25 vial | 2009-12-14 | 0000-00-00 | No | No | Current |
| 63323-403-04 | 63323040304 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 63323-403-10 | 63323040310 | 10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04) | 10 vial | 2009-12-14 | 0000-00-00 | No | No | Current |