Extended Phenytoin Sodium

Product NDC
50090-3165
11-digit product format
500903165
Labeler code
50090
Product ID
50090-3165_616412f7-f49a-4469-a8f0-dbe32697db74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204309
Marketing category
ANDA
Marketing start
2015-06-10
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3165-0EA - Each50090-3165d5bab16f-345a-47f3-b2c9-f4a2ae2c554712019-05-02
50090-3165-1EA - Each50090-316596fc9e84-d4fe-4b38-9e88-f3c00c9e5fbe12021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3165-050090316500100 CAPSULE in 1 BOTTLE (50090-3165-0) 100 capsule2017-10-120000-00-00NoNoCurrent
50090-3165-15009031650190 CAPSULE in 1 BOTTLE, PLASTIC (50090-3165-1) 90 capsule2015-06-100000-00-00NoNoCurrent