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 55 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLCVS Pharmacy, Inc.3ea2f838-3ad8-4913-8736-9da82f5cef4b2026-02-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLCVS Pharmacy, Inc.2adb16b7-c43f-49a0-9a56-fece3d7300892026-02-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Ethyl Rubbing AlcoholETHYL ALCOHOLCVS Pharmacy, Inc.b4238c3a-f6bc-4232-932e-bece539955662026-02-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Latalia Alcohol Antiseptic 80% SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTD2da50235-5d89-4774-9c92-bb22cee081f12026-02-03WarningsExact identifier
unii: 3K9958V90M
Latalia alcohol disinfectant wipesETHYL ALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD4ef3c800-1754-4d9c-81d6-5309db7b04cf2026-02-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Morning DewALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f60996-6a03-77e0-e063-6394a90a7a112026-02-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Wild Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f64148-5c63-0107-e063-6294a90a0c452026-02-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Incc97eae06-df1f-4f3e-bef3-66882a3898932026-02-02WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFourstar Group USA, Inc26ae8950-a770-4755-aa51-7e3a24cdae842026-02-02WarningsExact identifier
unii: 3K9958V90M
hand sanitizerHAND SANITIZERJINHUA YINKOU COSMETICS CO.,LTD49e26e51-6c32-7986-e063-6394a90a1d232026-02-02WarningsExact identifier
unii: 3K9958V90M
INSTANT HAND SANITIZERINSTANT HAND SANITIZERNINGBO MEITELI COSMETICS CO., LTD49e44671-5d79-aa8e-e063-6294a90a9d2e2026-02-02WarningsExact identifier
unii: 3K9958V90M
Phenytoin SodiumPHENYTOIN SODIUMProficient Rx LPf4353734-29b0-4027-824d-2fc97f778c672026-02-01Warnings, Adverse reactionsExact identifier
unii: 4182431BJH
BCBGENERATION Hand Sanitizer WHITE JASMINE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2c904dad-b8d9-49c5-9cbf-b5916f05c2c12026-01-31WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLRite Aid Corporationf7eb3c0e-4e53-45d8-88f9-95026f5e3efb2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLRite Aid Corporation5f474ef9-0459-4192-b31d-cbf69c7a2b9a2026-01-30Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer MARSHMALLOW SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3ce38e8c-8f57-480b-86be-8bf7681bbb882026-01-30WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAldi, Incaaa55815-ab6d-41c0-b04f-53de8001ebc72026-01-29WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLAmerisource Bergene2718f0e-14e9-4698-8400-f5dfe9169bf72026-01-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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