Phenytoin Sodium
- Product NDC
- 0641-2555
- 11-digit product format
- 006412555
- Labeler code
- 0641
- Product ID
- 0641-2555_1b68e42c-ebb1-4798-adba-712a41cd1cf4
- 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 |
|---|---|
| PHENYTOIN SODIUM | 50 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4182431BJH |
| Rxcui | 1670351, 1670353 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| be8c0c29-be12-4cae-8e3b-1c71ed6b952c | Product name | 2 | 20250626 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| e3d31abf-5149-4e77-89a8-0dc73ec106f9 | Product name | 1 | 20210525 |
| b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb | Product name | 2 | 20200303 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 031bbc61-0564-1f35-2716-aa5c1d139248 | Product name | 2 | 20141218 |
| cc830ceb-037c-a5c3-ee14-3d82c0e89e70 | Product name | 1 | 20140508 |
| eafc3fd3-6834-3129-5bbb-8a9a495691ab | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-2555-10 | Phenytoin Sodium | 10 in 1 CARTON | INJECTION | 10 | 27 | |
| 0641-2555-41 | Phenytoin Sodium | 5 mL in 1 VIAL | INJECTION | 5 | 27 | |
| 0641-2555-45 | Phenytoin Sodium | 25 in 1 CARTON | INJECTION | 25 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-2555-10 | ML - Milliliter | 0641-2555 | 2c387154-2213-431b-ac08-43e66ab3415c | 1 | 2024-01-04 |
| 0641-2555-41 | ML - Milliliter | 0641-2555 | 4e2b7ec4-9ce3-48e0-b8b8-faf7914379ec | 1 | 2012-07-24 |
| 0641-2555-45 | ML - Milliliter | 0641-2555 | 698657cf-7999-407b-a4d4-854a01692203 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PHENYTOIN SODIUM | ACTIVE INGREDIENT | 4182431BJH | PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 13 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 13 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 13 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 13 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 13 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1670351 | phenytoin sodium 100 MG in 2 ML Injection | PSN | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670353 | phenytoin sodium 250 MG in 5 ML Injection | PSN | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670351 | 2 ML phenytoin sodium 50 MG/ML Injection | SCD | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670353 | 5 ML phenytoin sodium 50 MG/ML Injection | SCD | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670351 | 2 ML DPH sodium 50 MG/ML Injection | SY | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670353 | 5 ML DPH sodium 50 MG/ML Injection | SY | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670351 | phenytoin sodium 100 MG per 2 ML Injection | SY | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670353 | phenytoin sodium 250 MG per 5 ML Injection | SY | 035a8d4e-2063-4240-83cb-d7eebcabe301 | 27 |
| 1670353 | phenytoin sodium 250 MG in 5 ML Injection | PSN | 763b549d-9b78-09dd-e053-2a91aa0aec7f | 4 |
| 1670353 | 5 ML phenytoin sodium 50 MG/ML Injection | SCD | 763b549d-9b78-09dd-e053-2a91aa0aec7f | 4 |
| 1670353 | 5 ML DPH sodium 50 MG/ML Injection | SY | 763b549d-9b78-09dd-e053-2a91aa0aec7f | 4 |
| 1670353 | phenytoin sodium 250 MG per 5 ML Injection | SY | 763b549d-9b78-09dd-e053-2a91aa0aec7f | 4 |
| 1670353 | phenytoin sodium 250 MG in 5 ML Injection | PSN | a52cf1bd-dc1f-47be-aba8-29066d9a50fb | 1 |
| 1670353 | 5 ML phenytoin sodium 50 MG/ML Injection | SCD | a52cf1bd-dc1f-47be-aba8-29066d9a50fb | 1 |
| 1670353 | 5 ML DPH sodium 50 MG/ML Injection | SY | a52cf1bd-dc1f-47be-aba8-29066d9a50fb | 1 |
| 1670353 | phenytoin sodium 250 MG per 5 ML Injection | SY | a52cf1bd-dc1f-47be-aba8-29066d9a50fb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-2555-10 | 00641255510 | 10 VIAL in 1 CARTON (0641-2555-10) / 5 mL in 1 VIAL (0641-2555-41) | 10 vial | 2023-09-21 | No | No | Historical | |
| 0641-2555-41 | 00641255541 | 5 mL in 1 VIAL | 5 ml | Historical | ||||
| 0641-2555-45 | 00641255545 | 25 VIAL in 1 CARTON (0641-2555-45) / 5 mL in 1 VIAL (0641-2555-41) | 25 vial | 1975-07-16 | 0000-00-00 | No | No | Current |