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 33 of 154 · 3,066 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMMINOXIDILPutian Licheng District Zhijiancheng Trading Co., Ltd.5009b231-23c3-7356-e063-6394a90a569f2026-04-22WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes LavenderALCOHOLThe Honest Company Inc.4a69b1d5-81ad-2cd1-e063-6294a90ac62d2026-04-22WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes GrapefruitALCOHOLThe Honest Company Inc.4aa8c899-e5c3-9eec-e063-6294a90a6eae2026-04-22WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Golden Tangerine ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO82c7f67c-dca8-4859-b945-db34a039cc3d2026-04-22WarningsExact identifier
unii: 3K9958V90M
3M Avagard DALCOHOLSolventum US LLC220c8a49-2a52-4660-8ad4-de553bd032262026-04-22WarningsExact identifier
unii: 3K9958V90M
3M AvagardCHLORHEXIDINE GLUCONATE AND ALCOHOLSolventum US LLC8bf8fe8e-76cb-4eda-a18d-1687050285ae2026-04-22WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited0f96981b-6ba0-4993-b35e-4d430b0f44ff2026-04-22WarningsExact identifier
unii: 3K9958V90M
Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry CrumbleALCOHOL SPRAYScent Theory Products LLC4ffa6e26-870f-586e-e063-6394a90ad9752026-04-21WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLTarget Corporation5c6be1e4-ae02-430c-8ed7-2148660da19d2026-04-21Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Phenytoin SodiumPHENYTOIN SODIUMGolden State Medical Supply, Inc.36262a4c-33f1-40a5-e063-6394a90ad36a2026-04-21Warnings, Adverse reactionsExact identifier
unii: 4182431BJH
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
unii: 3K9958V90M
Smart Care APPLE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3a377d37-28c3-4cd6-8633-8b13464a28ef2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.24534267-52d9-47c9-bb83-913c3a0f29d12026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care PUMPKIN SPICE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5f7ddccc-58da-4c86-b2b4-9de17e12922d2026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care CANDY CANE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.84b0158c-4450-4a15-a01d-8592ae8c9c162026-04-17WarningsExact identifier
unii: 3K9958V90M
Smart Care BOTANIC BLUSH HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4978df06-8dc2-4dc5-a626-6bcb61e7d0ac2026-04-17WarningsExact identifier
unii: 3K9958V90M
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC249e00ef-fe9d-dc07-e063-6394a90a9f4c2026-04-16WarningsExact identifier
unii: 3K9958V90M
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC2d940d35-6a73-e494-e063-6394a90a9d162026-04-14WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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