FDA.reportPublic FDA data

NDC 0641-2555-41 - PHENYTOIN SODIUM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0641-2555
Requested NDC
0641-2555-41
Package NDCs from labels
0641-2555-41, 0641-2555-10, 0641-2555-45
Manufacturer
Henry Schein, Inc.
Effective date
2024-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENYTOIN SODIUM - Henry Schein, Inc.Henry Schein, Inc.2024-12-26HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - Henry Schein, Inc.Henry Schein, Inc.2024-08-19HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - General Injectables & Vaccines, Inc.General Injectables & Vaccines, Inc.2022-12-29HUMAN PRESCRIPTION DRUG LABEL
PHENYTOIN SODIUM - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-2555-10Phenytoin Sodium10 in 1 CARTONINJECTION1027
0641-2555-41Phenytoin Sodium5 mL in 1 VIALINJECTION527
0641-2555-45Phenytoin Sodium25 in 1 CARTONINJECTION2527

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-2555PHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]27Current NDC, Legacy NDC, 3 package rows20240410_035a8d4e-2063-4240-83cb-d7eebcabe301.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-2555-10ML - Milliliter0641-25552c387154-2213-431b-ac08-43e66ab3415c12024-01-04
0641-2555-41ML - Milliliter0641-25554e2b7ec4-9ce3-48e0-b8b8-faf7914379ec12012-07-24
0641-2555-45ML - Milliliter0641-2555698657cf-7999-407b-a4d4-854a0169220312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]13
Phenytoin SodiumACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM (PHENYTOIN SODIUM ) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM (PHENYTOIN SODIUM ) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 30 of 153 · 3,048 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalgreensETHYL ALCOHOLWalgreenebf222f0-dc46-ee73-e053-2a95a90a07212026-05-08WarningsExact identifier
unii: 3K9958V90M
WalgreensETHYL ALCOHOLWalgreensebf222f0-dc45-ee73-e053-2a95a90a07212026-05-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLApollo Health and Beauty Care35a64b83-12b2-3d69-e063-6294a90a19e72026-05-08WarningsExact identifier
unii: 3K9958V90M
Autumn Bliss Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Carea259d254-52ae-4612-aa9e-a36480ad151a2026-05-08WarningsExact identifier
unii: 3K9958V90M
Winter Frost Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Careac3577f8-f3be-4dc7-a4da-652688c32d062026-05-08WarningsExact identifier
unii: 3K9958V90M
Sweet Cinnamon Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Carefa78fb62-ca61-4fc8-a11a-74340dfa3d662026-05-08WarningsExact identifier
unii: 3K9958V90M
Kleenex Ultra Moisturizing Hand SanitizerALCOHOLKimberly-Clark Corporation75e884bf-8e0d-41e7-adbb-4400ee3d1e072026-05-08WarningsExact identifier
unii: 3K9958V90M
XHC-075ALCOHOLEcolab Inc.708d0018-372b-4fde-b408-f4be030f26632026-05-07WarningsExact identifier
unii: 3K9958V90M
Natural Concepts Hand SanitizerETHYL ALCOHOLApollo Health and Beauty Careb25bbf28-f08d-4de2-9be7-bfb6b134b49a2026-05-07WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGiant Eagled384d3f3-a3c8-a98d-e053-2995a90ab9bf2026-05-07WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.fb93b4f6-9eaf-4c35-a110-1f526ca7c3732026-05-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.57f60d9e-954d-413d-ab3b-e4b800d072bf2026-05-06WarningsExact identifier
unii: 3K9958V90M
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsExact identifier
unii: 3K9958V90M
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
unii: 3K9958V90M
GuardALCOHOLApollo Health and Beauty Carefdc99948-1bd0-cdf2-e053-6394a90aaf972026-05-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.