Dilantin-125

Product NDC
0071-2214
11-digit product format
000712214
Labeler code
0071
Product ID
0071-2214_2290658d-13e5-43f6-805f-614c8baa613c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Parke-Davis Div of Pfizer Inc
Application
NDA008762
Marketing category
NDA
Marketing start
1953-01-06
Marketing end
0000-00-00
Substance
PHENYTOIN
Active strength
125 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-2214-20ML - Milliliter0071-2214642ecd69-9d42-48b0-9dc3-7fbce551b9c312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-2214-2000071221420237 mL in 1 BOTTLE, GLASS (0071-2214-20) 237 ml1953-01-060000-00-00NoNoCurrent
0071-2214-35000712214351 BOTTLE, PLASTIC in 1 CARTON (0071-2214-35) > 237 mL in 1 BOTTLE, PLASTIC2020-10-120000-00-00NoNoCurrent