Phenytoin Sodium
- Product NDC
- 52584-555
- 11-digit product format
- 525840555
- Labeler code
- 52584
- Product ID
- 52584-555_c908604b-b1b2-457f-800c-9b2ee55fdf53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables & Vaccines, Inc.
- Application
- ANDA084307
- Marketing category
- ANDA
- Marketing start
- 2011-08-30
- Marketing end
- 2023-04-30
- Substance
- PHENYTOIN SODIUM
- Active strength
- 250 mg/5mL
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-555-41 | 52584055541 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-555-41) > 5 mL in 1 VIAL, SINGLE-DOSE | 2011-08-30 | 0000-00-00 | No | No | Current |