PHENYTOIN SODIUM

Product NDC
63629-6364
11-digit product format
636296364
Labeler code
63629
Product ID
63629-6364_9b989e88-a9d3-4e6b-b617-1da77a48684d
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
63629-6364-12020-10-16C16284748780-19d75b9d0-ad8f-f424-e053-dadaa90a57ce5a61de7f-c008-418b-bde6-4e14d79d89e5
63629-6364-12020-01-31C16284748780-19d75b9d0-ad8f-f424-e053-dadaa90a57ce5a61de7f-c008-418b-bde6-4e14d79d89e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-6364-16362963640190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-6364-1) 2015-09-090000-00-00NoNoCurrent