Phenytoin Sodium
- Product NDC
- 52584-493
- 11-digit product format
- 525840493
- Labeler code
- 52584
- Product ID
- 52584-493_2bb4a206-2c18-4fc6-8e55-49c0209be231
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- ANDA084307
- Marketing category
- ANDA
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-493-21 | 52584049321 | 1 VIAL in 1 BAG (52584-493-21) > 2 mL in 1 VIAL | 1 vial | 2010-03-01 | 0000-00-00 | No | No | Current |