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 57 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLMY IMPORTS USA LLC48f2527c-a83e-f709-e063-6394a90aa0302026-01-21WarningsExact identifier
unii: 3K9958V90M
Walgreens SWEET PEA PETALS Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.9867c899-980b-4272-8716-41e7c27cdcb82026-01-21WarningsExact identifier
unii: 3K9958V90M
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand Sanitizing WipesALCOHOLGerms Be Gone LLC2bd6249b-f215-7aa9-e063-6394a90a65802026-01-20WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER SUMMER LEMONETHYL ALCOHOLRejoice International Corp.48dd563a-0558-cc76-e063-6294a90ab0412026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care COCO CABANA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.026aff02-33cf-486d-ae7f-0f0913ce83992026-01-20WarningsExact identifier
unii: 3K9958V90M
Walgreens PEAR Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.a89f90e1-0696-4688-9503-5e6b3e7853bd2026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS SUNSET HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.de33db2f-9329-4c42-b67f-de5358c547aa2026-01-19WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET AND STILL HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.1086c3cd-5081-49ed-8380-7a7f31488f532026-01-19WarningsExact identifier
unii: 3K9958V90M
Walgreens WATERMELON Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.08952596-4a48-4792-9d4d-008590c713122026-01-17WarningsExact identifier
unii: 3K9958V90M
Smart Care MORNING DEW HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.7a3915c6-8f40-4c08-a5c1-ea28ed583df72026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care ROSEBUD HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e6d8afb6-7f6c-4093-b4fb-ec66a998273b2026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care SEA BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.d98cddef-e846-4e6f-939b-d854221399f72026-01-16WarningsExact identifier
unii: 3K9958V90M
Smart Care TROPICAL MANGO HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5f4744c2-da0e-41ca-b5a5-2829cbf0cb1e2026-01-16WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
unii: 3K9958V90M
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487b648a-1680-6de5-e063-6394a90ab8522026-01-16WarningsExact identifier
unii: 3K9958V90M
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487e6851-1ca3-f9db-e063-6394a90a56f12026-01-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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