Extended Phenytoin Sodium

Product NDC
71335-1349
11-digit product format
713351349
Labeler code
71335
Product ID
71335-1349_c7f2ab13-f433-4f50-b8e2-c3a3742e07af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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], 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1349-171335134901100 CAPSULE in 1 BOTTLE (71335-1349-1) 100 capsule2019-09-240000-00-00NoNoCurrent
71335-1349-27133513490230 CAPSULE in 1 BOTTLE (71335-1349-2) 30 capsule2020-10-130000-00-00NoNoCurrent
71335-1349-371335134903180 CAPSULE in 1 BOTTLE (71335-1349-3) 180 capsule2020-10-130000-00-00NoNoCurrent
71335-1349-47133513490490 CAPSULE in 1 BOTTLE (71335-1349-4) 90 capsule2020-10-130000-00-00NoNoCurrent
71335-1349-571335134905120 CAPSULE in 1 BOTTLE (71335-1349-5) 120 capsule2020-10-130000-00-00NoNoCurrent
71335-1349-67133513490660 CAPSULE in 1 BOTTLE (71335-1349-6) 60 capsule2020-10-130000-00-00NoNoCurrent
71335-1349-771335134907270 CAPSULE in 1 BOTTLE (71335-1349-7) 270 capsule2020-10-020000-00-00NoNoCurrent