Extended Phenytoin Sodium

Product NDC
68084-376
11-digit product format
680840376
Labeler code
68084
Product ID
68084-376_eb8f29b8-c9dc-0c1e-e053-2995a90a6d3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040765
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
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
68084-376-01EA - Each68084-3760d78eab8-797f-4460-9c21-e3124e7bb86312012-07-24
68084-376-11EA - Each68084-376dbf1871f-6caa-4455-91af-b22eb6f1918a12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-376-0168084037601100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-376-01) > 1 CAPSULE in 1 BLISTER PACK (68084-376-11) 100 blister pack2010-05-170000-00-00NoNoCurrent