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 49 of 153 · 3,045 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Moisturizing Hand Sanitizer Iced Lemon Pound CakeALCOHOLBath & Body Works, Inc.387ca6e9-38ec-2519-e063-6394a90a42112026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Rose Water and IvyALCOHOLBath & Body Works, Inc.387caf6b-fd9c-a63f-e063-6294a90a041a2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Fresh Coconut and CottonALCOHOLBath & Body Works, Inc.29a27bb2-2edd-6e6d-e063-6394a90a4fb22026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Pomegranate and BlackberryALCOHOLBath & Body Works, Inc.387ca290-1d8a-abb7-e063-6294a90a12ff2026-03-02WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Afternoon Apple PickingALCOHOLBath & Body Works, Inc.369ac581-c59b-4eb5-e063-6394a90aec7a2026-03-02WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER lsland CoconutALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf3a822-27d2-efef-e063-6294a90a05022026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Cherry BlossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf48a93-345d-b901-e063-6394a90ab41b2026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Cucumber MelonALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf552a4-b8b3-6fe3-e063-6394a90a722a2026-03-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLThe Kroger Co.9f95d956-25db-4ffa-86cc-a160677124b82026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
PHENYTOIN SODIUMPHENYTOIN SODIUMDIRECT RXdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2142026-02-27Warnings, Adverse reactionsExact identifier
unii: 4182431BJH
Ethyl alcoholETHYL ALCOHOLWalmart Inc.f7d9bb83-0b80-458b-9554-8adbe51473e42026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLWalmart Inc.2112ba04-1584-46dd-9a7b-2dfd27e501b72026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLWalmart Inc.c05bcb17-f1f6-4e3a-b90a-5d003ce5215b2026-02-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Dial Professional Gel SanitizerDIAL PROFESSIONAL GEL HAND SANITIZERHenkel Corporation2862ab27-b5e7-8bdb-e063-6394a90abf802026-02-27WarningsExact identifier
unii: 3K9958V90M
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION HAND SANITIZER WILD Cherry SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOdc344dee-1a46-49cb-bead-227f64bc04ea2026-02-27WarningsExact identifier
unii: 3K9958V90M
RubbingETHYL ALCOHOLUnited Natural Foods, Inc. dba UNFIcd03611f-879a-4888-8d45-f8bdfd82529c2026-02-26Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Avant Original - Fragrance FreeALCOHOLB4 Soap LLC35a2d0ba-9209-4d70-b3b4-537225f83c842026-02-26WarningsExact identifier
unii: 3K9958V90M
Advanced Hand Sanitizer with AloeADVANCED HAND SANITIZER WITH ALOEChain Drug Marketing Association4977f769-7dc9-be56-e063-6394a90a852c2026-02-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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