Phenytoin Sodium

Product NDC
0404-9933
11-digit product format
004049933
Labeler code
0404
Product ID
0404-9933_00f9a538-630f-48d7-8083-33284ecb1ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA084307
Marketing category
ANDA
Marketing start
2022-01-13
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9933-05004049933051 VIAL, SINGLE-DOSE in 1 BAG (0404-9933-05) > 5 mL in 1 VIAL, SINGLE-DOSE2022-01-130000-00-00NoNoCurrent