PHENYTOIN SODIUM
- Product NDC
- 51662-1251
- 11-digit product format
- 516621251
- Labeler code
- 51662
- Product ID
- 51662-1251_0f8e2789-a18e-bfe6-e063-6394a90abbe9
- 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
- 2018-09-16
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1251-1 | PHENYTOIN SODIUM | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 6 |
| 51662-1251-2 | PHENYTOIN SODIUM | 2 mL in 1 VIAL | INJECTION | 2 | | 6 |
| 51662-1251-2 | PHENYTOIN SODIUM | 1 in 1 POUCH | INJECTION | 1 | | 6 |
| 51662-1251-3 | PHENYTOIN SODIUM | 25 in 1 BOX | INJECTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1251 | PHENYTOIN SODIUM INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240123_7607ddff-2f1c-272c-e053-2991aa0a1ab3.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 |
|---|
| 51662-1251-1 | 51662125101 | 2 mL in 1 VIAL, SINGLE-DOSE (51662-1251-1) | 2 ml | 2018-09-16 | 0000-00-00 | No | No | Current |
| 51662-1251-2 | 51662125102 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 51662-1251-3 | 51662125103 | 25 POUCH in 1 BOX (51662-1251-3) / 1 VIAL in 1 POUCH (51662-1251-2) / 2 mL in 1 VIAL | 25 pouch | 2022-03-16 | 0000-00-00 | No | No | Current |