FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
50090-5700
11-digit product format
500905700
Labeler code
50090
Product ID
50090-5700_452ba779-0f51-4e9d-a661-e3db5078e950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040684
Marketing category
ANDA
Marketing start
2017-07-24
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenytoin Sodium
Listing expiration
2026-12-31

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
50090-5700-02024-05-22C16284748780-11030e365-2f92-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-5700-12024-05-22C16284748780-11030e365-2f92-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-5700-02024-01-30C16284748780-11030e365-2f92-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
50090-5700-12024-01-30C16284748780-11030e365-2f92-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5700-0Phenytoin Sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
50090-5700-1Phenytoin Sodium90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5700-0EA - Each50090-5700b6279dc9-526a-41f9-a7b2-eee5d051c6df12022-08-04
50090-5700-1EA - Each50090-57000709952f-5746-467a-b556-80eb97a9a4a812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5700PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240524_d4459837-da26-4c97-8587-32eb1f682d58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNd4459837-da26-4c97-8587-32eb1f682d585
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDd4459837-da26-4c97-8587-32eb1f682d585
855671DPH sodium 100 MG Extended Release Oral CapsuleSYd4459837-da26-4c97-8587-32eb1f682d585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5700-050090570000100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5700-0) 2021-09-230000-00-00NoNoCurrent
50090-5700-15009057000190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5700-1) 2021-09-240000-00-00NoNoCurrent