FDA.reportPublic FDA data

Extended Phenytoin Sodium

Product NDC
60687-841
11-digit product format
606870841
Labeler code
60687
Product ID
60687-841_2d7feada-3c36-9b2e-e063-6294a90ab409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA204309
Marketing category
ANDA
Marketing start
2025-02-06
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
Extended 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-841-01Extended Phenytoin Sodium100 in 1 CARTONCAPSULE1002
60687-841-11Extended Phenytoin Sodium1 in 1 BLISTER PACKCAPSULE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-841-01EA - Each60687-841efa4c77b-8b23-41a6-963a-20cc87a81d7512024-10-04
60687-841-11EA - Each60687-841dda5335f-2ba3-48f8-b00c-766e3c1109a912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-841EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250209_5b64cb11-673a-41ec-9b2a-1e194ae5eb0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN5b64cb11-673a-41ec-9b2a-1e194ae5eb0c2
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD5b64cb11-673a-41ec-9b2a-1e194ae5eb0c2
855671DPH sodium 100 MG Extended Release Oral CapsuleSY5b64cb11-673a-41ec-9b2a-1e194ae5eb0c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-841-0160687084101100 BLISTER PACK in 1 CARTON (60687-841-01) / 1 CAPSULE in 1 BLISTER PACK (60687-841-11) 100 blister pack2025-02-06NoNoHistorical
60687-841-11606870841111 in 1 BLISTER PACKHistorical