PHENYTOIN SODIUM
- Product NDC
- 51662-1250
- 11-digit product format
- 516621250
- Labeler code
- 51662
- Product ID
- 51662-1250_ef6a784b-3d13-da51-e053-2a95a90ad05d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENYTOIN SODIUM
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA084307
- Marketing category
- ANDA
- Marketing start
- 2018-09-19
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1250-1 | PHENYTOIN SODIUM | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1250 | PHENYTOIN SODIUM INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 1 package rows | 20221211_763b549d-9b78-09dd-e053-2a91aa0aec7f.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 |
|---|
| 51662-1250-1 | 51662125001 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1250-1) | 5 ml | 2018-09-19 | 0000-00-00 | No | No | Current |