Extended Phenytoin Sodium

Product NDC
50090-2089
11-digit product format
500902089
Labeler code
50090
Product ID
50090-2089_6ab8bd91-97c8-4a79-9310-f128bb8dd46a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040765
Marketing category
ANDA
Marketing start
2009-12-16
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2089-0EA - Each50090-2089e046d22d-8c41-4720-a0a4-fb69117c96fc12021-09-07
50090-2089-1EA - Each50090-208900a2c17f-6258-44fb-ada0-4f6a11d8460412021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2089-050090208900100 CAPSULE in 1 BOTTLE (50090-2089-0) 100 capsule2015-10-090000-00-00NoNoCurrent
50090-2089-15009020890190 CAPSULE in 1 BOTTLE (50090-2089-1) 90 capsule2019-12-030000-00-00NoNoCurrent