PHENYTOIN SODIUM
- Product NDC
- 0404-9808
- 11-digit product format
- 004049808
- Labeler code
- 0404
- Product ID
- 0404-9808_5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phenytoin sodium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA084307
- Marketing category
- ANDA
- Marketing start
- 2024-12-26
- Substance
- PHENYTOIN 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
- PHENYTOIN SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYTOIN SODIUM | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4182431BJH |
| Rxcui | 1670353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9808-05 | PHENYTOIN SODIUM | 1 in 1 BAG | INJECTION | 1 | | 1 |
| 0404-9808-05 | PHENYTOIN SODIUM | 5 mL in 1 VIAL | INJECTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9808 | PHENYTOIN SODIUM INJECTION [HENRY SCHEIN, INC.] | 1 | Current NDC, 2 package rows | 20250112_a52cf1bd-dc1f-47be-aba8-29066d9a50fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9808-05 | 00404980805 | 1 VIAL in 1 BAG (0404-9808-05) / 5 mL in 1 VIAL | 1 vial | 2024-12-26 | No | No | Current |