FDA.reportPublic FDA data

NDC 0641-6138-01 - 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
0641-6138
Requested NDC
0641-6138-01
Package NDCs from labels
0641-6138-01, 0641-6138-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin Sodium - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6138-01Phenytoin Sodium2 mL in 1 VIALINJECTION221
0641-6138-25Phenytoin Sodium25 in 1 CARTONINJECTION2521

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6138PHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]21Current NDC, Legacy NDC, 2 package rows20240410_8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6138-01ML - Milliliter0641-6138ec77a16e-2875-4829-86a7-607a0d096ec712013-05-02
0641-6138-25ML - Milliliter0641-6138a368c14d-8dab-409e-a72c-40f59da8cd7c12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7

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 65 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLAjenat Pharmaceuticals LLC636d6421-cadf-42b3-a431-ba40c06e36d22025-12-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PISTACHIO MATCHA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limiteddfd59d2e-9036-486a-b25b-7e5fe23421ce2025-12-26WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHANOLZep Inc.c72cf71f-e639-2854-e053-2a95a90ab30e2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Handstand Instant Hand SanitizerETHYL ALCOHOLZep Inc.9984beca-a66a-785c-e053-2995a90ae5ba2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Hand Sanitizer WipesETHANOLZep Inc.99867fc5-820e-6d6b-e053-2a95a90a07932025-12-26WarningsExact identifier
unii: 3K9958V90M
StellaLife Hand SanitizerALCOHOLStellaLife, Inc.a65b338d-5019-0cfc-e053-2a95a90ae8b22025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SUNDAE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedddda3587-1967-474a-8d9b-c6dad5448b2c2025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY KISS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited39c8767d-46e8-4b26-be52-e5ed7d090d3e2025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY CLOUDS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6cac3768-0622-4151-abf5-97903ce1ea0e2025-12-26WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Lavender ChamomileALCOHOLTazza Brands East Inc.3c9afa9e-5109-bd0b-e063-6394a90ad8e52025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Peppermint LemonALCOHOLTazza Brands East Inc.3ddd9fa7-5e24-0781-e063-6394a90ae9512025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Sweet Orange Vanilla SpiceALCOHOLTazza Brands East Inc.3dddc20c-5dba-2e19-e063-6394a90aac7f2025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER UNSCENTEDALCOHOLTazza Brands East Inc.3de26f8e-83ea-c04f-e063-6294a90ac0242025-12-25WarningsExact identifier
unii: 3K9958V90M
Tazza 70% Alcohol-Based Hand Sanitizing FoamALCOHOLTazza Brands East, Inc.33452d7a-0436-99bb-e063-6294a90ad8c42025-12-24WarningsExact identifier
unii: 3K9958V90M
tazza-X EXTREME 63% alcohol formula HAND SANITIZINGALCOHOLTazza Brands East Inc.3a073e9c-d6e6-e2d9-e063-6394a90a61532025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist StrawberryETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf545a-0f53-4fc0-e063-6294a90a89012025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist PeachETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf6f89-4a8d-86ad-e063-6294a90a97c32025-12-24WarningsExact identifier
unii: 3K9958V90M
AMORA Hand Sanitizer Mist WatermelonETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf871e-cb82-cf46-e063-6394a90a92962025-12-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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