PHENYTOIN SODIUM

Product NDC
63629-6382
11-digit product format
636296382
Labeler code
63629
Product ID
63629-6382_17021b5f-c1c3-4316-81c6-68cb0d89cc34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040621
Marketing category
ANDA
Marketing start
2006-12-12
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-6382-12020-10-16C16284748780-19d75b9d0-818e-f424-e053-dadaa90a57ced57cbadc-da16-4107-a95f-2b70bd965642
63629-6382-12020-01-31C16284748780-19d75b9d0-818e-f424-e053-dadaa90a57ced57cbadc-da16-4107-a95f-2b70bd965642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-6382-16362963820190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-6382-1) 2015-09-040000-00-00NoNoCurrent