Extended Phenytoin Sodium

Product NDC
0904-6187
11-digit product format
009046187
Labeler code
0904
Product ID
0904-6187_8a71ec29-abd6-4c6c-bda3-7fa45a7ad9b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
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
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
0904-6187-61EA - Each0904-6187dd1b646d-a0ae-4706-96fe-2bd67fc3707212016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6187-6100904618761100 BLISTER PACK in 1 CARTON (0904-6187-61) > 1 CAPSULE in 1 BLISTER PACK100 blister pack2009-12-160000-00-00NoNoCurrent