Phenytoin Sodium

Product NDC
55154-5496
11-digit product format
551545496
Labeler code
55154
Product ID
55154-5496_b52eb2d9-d274-4125-bca4-dc8645dcf69f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA040298
Marketing category
ANDA
Marketing start
2011-01-28
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-5496-0EA - Each55154-54967d95a305-1122-4fed-9fe2-40e125cf2b1a12020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5496-05515454960010 BLISTER PACK in 1 BAG (55154-5496-0) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2011-01-280000-00-00NoNoCurrent