FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
71610-934
11-digit product format
716100934
Labeler code
71610
Product ID
71610-934_3dd660a7-5ba3-d993-e063-6394a90aeda9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040684
Marketing category
ANDA
Marketing start
2006-09-05
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-934-92Phenytoin Sodium270 in 1 BOTTLECAPSULE, EXTENDED RELEASE2703
71610-934-94Phenytoin Sodium360 in 1 BOTTLECAPSULE, EXTENDED RELEASE3603
71610-934-98Phenytoin Sodium540 in 1 BOTTLECAPSULE, EXTENDED RELEASE5403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-934-92EA - Each71610-934c6c0bc4a-db9d-4bca-839c-5e91a23c48f512025-10-14
71610-934-94EA - Each71610-934154388b4-41ad-48e4-998c-5c11ea9a5ecc12025-09-12
71610-934-98EA - Each71610-93464ea8049-293f-4f20-870f-91c1510ab25912025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN3bc82d23-3950-f181-e063-6394a90ad5653
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD3bc82d23-3950-f181-e063-6394a90ad5653
855671DPH sodium 100 MG Extended Release Oral CapsuleSY3bc82d23-3950-f181-e063-6394a90ad5653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-934-9271610093492270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-934-92) 2025-09-02NoNoHistorical
71610-934-9471610093494360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-934-94) 2025-08-06NoNoHistorical
71610-934-9871610093498540 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-934-98) 2025-08-18NoNoHistorical