Phenytoin Sodium

Product NDC
63629-2369
11-digit product format
636292369
Labeler code
63629
Product ID
63629-2369_3ab204d7-6de5-4ff5-9e37-69d96e0bf58d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040684
Marketing category
ANDA
Marketing start
2017-07-24
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2369-1EA - Each63629-2369ec53b41d-7043-46a1-86cd-d916b61e09fd12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2369PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]107Legacy NDC20241108_eacd7c56-d2c5-4aa4-9f78-b8384ba874b6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2369-1636292369011000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2369-1) 2017-07-240000-00-00NoNoCurrent