Phenytoin Sodium
- Product NDC
- 71872-7079
- 11-digit product format
- 718727079
- Labeler code
- 71872
- Product ID
- 71872-7079_0aaca355-f97c-6453-e063-6394a90a07bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Medical Purchasing Solutions, LLC
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71872-7079-1 | Phenytoin Sodium | 1 in 1 BAG | INJECTION | 1 | | 1 |
| 71872-7079-1 | Phenytoin Sodium | 2 mL in 1 VIAL | INJECTION | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71872-7079 | PHENYTOIN SODIUM INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 1 | Current NDC, 2 package rows | 20231122_0aac9dcd-c4df-84d9-e063-6294a90a0376.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 |
|---|
| 71872-7079-1 | 71872707901 | 1 VIAL in 1 BAG (71872-7079-1) / 2 mL in 1 VIAL | 1 vial | 2023-09-25 | No | No | Historical |