Phenytoin Sodium
- Product NDC
- 0641-6139
- 11-digit product format
- 006416139
- Labeler code
- 0641
- Product ID
- 0641-6139_8c2cd4dc-57c1-48b8-8005-95c5a5593e7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA084307
- Marketing category
- ANDA
- Marketing start
- 1975-07-16
- 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 | 1670351, 1670353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6139-01 | Phenytoin Sodium | 5 mL in 1 VIAL | INJECTION | 5 | | 21 |
| 0641-6139-10 | Phenytoin Sodium | 10 in 1 CARTON | INJECTION | 10 | | 21 |
| 0641-6139-25 | Phenytoin Sodium | 25 in 1 CARTON | INJECTION | 25 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6139 | PHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 21 | Current NDC, Legacy NDC, 3 package rows | 20240410_8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7.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 |
|---|
| 0641-6139-01 | 00641613901 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 0641-6139-10 | 00641613910 | 10 VIAL in 1 CARTON (0641-6139-10) / 5 mL in 1 VIAL (0641-6139-01) | 10 vial | 2023-09-22 | | No | No | Current |
| 0641-6139-25 | 00641613925 | 25 VIAL in 1 CARTON (0641-6139-25) / 5 mL in 1 VIAL (0641-6139-01) | 25 vial | 1975-07-16 | 0000-00-00 | No | No | Current |