FDA.reportPublic FDA data

PHENYTOIN SODIUM

Product NDC
61919-815
11-digit product format
619190815
Labeler code
61919
Product ID
61919-815_4bd28a50-22df-5238-e063-6294a90a6eec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040765
Marketing category
ANDA
Marketing start
2014-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENYTOIN SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-815-302023-01-30C16284748780-1f386c649-a2e9-0266-e053-dadaa90a7c1aPHENYTOIN SODIUM
61919-815-712023-01-30C16284748780-1f386c649-a2e9-0266-e053-dadaa90a7c1aPHENYTOIN SODIUM
61919-815-722023-01-30C16284748780-1f386c649-a2e9-0266-e053-dadaa90a7c1aPHENYTOIN SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-815-30PHENYTOIN SODIUM30 in 1 BOTTLECAPSULE304
61919-815-71PHENYTOIN SODIUM100 in 1 BOTTLECAPSULE1004
61919-815-72PHENYTOIN SODIUM120 in 1 BOTTLECAPSULE1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-815-30EA - Each61919-815fdf9f36d-54bc-4ede-b08a-d72cec73f61c12015-10-02
61919-815-71EA - Each61919-8150f6f201c-ebfa-4ed9-8c97-20d2615adbf012015-03-03
61919-815-72EA - Each61919-81571220e75-84b7-4a98-8c7d-231dbcc9634d12018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE [DIRECT RX]1
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-815PHENYTOIN SODIUM CAPSULE [DIRECT RX]3Current NDC, Legacy NDC, 3 package rows20200130_df0bf42b-ce9a-42c3-8c24-46f1ea3bd214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2144
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2144
855671DPH sodium 100 MG Extended Release Oral CapsuleSYdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-815-306191908153030 CAPSULE in 1 BOTTLE (61919-815-30) 30 capsule2014-01-010000-00-00NoNoCurrent
61919-815-7161919081571100 CAPSULE in 1 BOTTLE (61919-815-71) 100 capsule2014-01-010000-00-00NoNoCurrent
61919-815-7261919081572120 CAPSULE in 1 BOTTLE (61919-815-72) 120 capsule2014-01-010000-00-00NoNoCurrent