FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
57664-808
11-digit product format
576640808
Labeler code
57664
Product ID
57664-808_23fd1e2c-9a41-54f3-e063-6394a90aeddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-808-18Phenytoin Sodium1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10008
57664-808-88Phenytoin Sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-808-18EA - Each57664-808a5994328-a0e9-4a4b-bbd4-3c8ffda9a33e12018-07-03
57664-808-88EA - Each57664-808ccc55f3e-84d7-4d92-8a1c-dc2b30fb6ff012018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-808PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 2 package rows20241010_92e98c47-abba-4018-99b6-a1fffed6db8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN6b4c2885-eae0-4c88-ada3-62a699df1dbb102
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD6b4c2885-eae0-4c88-ada3-62a699df1dbb102
855671DPH sodium 100 MG Extended Release Oral CapsuleSY6b4c2885-eae0-4c88-ada3-62a699df1dbb102
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
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN4fb35f26-1cbd-4fc2-867d-78bf95832f861
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD4fb35f26-1cbd-4fc2-867d-78bf95832f861
855671DPH sodium 100 MG Extended Release Oral CapsuleSY4fb35f26-1cbd-4fc2-867d-78bf95832f861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-808-18576640808181000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-808-18) 2017-07-240000-00-00NoNoCurrent
57664-808-8857664080888100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-808-88) 2017-07-240000-00-00NoNoCurrent