Phenytoin Sodium

Product NDC
58118-4111
11-digit product format
581184111
Labeler code
58118
Product ID
58118-4111_b02680e2-2284-73b9-e053-2a95a90aa899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA040684
Marketing category
ANDA
Marketing start
2019-03-07
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
58118-4111-82024-01-30C16284748780-11030e365-1cc2-111a-e063-dadaa90a10e21884b719-ca9e-42a1-bf5c-38f2de8d66ff

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-4111PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]3Legacy NDC20200926_1884b719-ca9e-42a1-bf5c-38f2de8d66ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-4111-85811841110830 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58118-4111-8) 2019-03-070000-00-00NoNoCurrent