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 72 of 153 · 3,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Lerna Antiseptic Sanitizing Hand GelALCOHOLLernapharm Loris Inc.444f3c7e-8403-1385-e063-6294a90a253b2025-11-23WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer MistETHYAL ALCOHOLZHEJIANG GAORONG COSMETIC CO.,LTD.44171307-78c7-c79c-e063-6294a90a06712025-11-21WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Citrus CrushALCOHOLI World LLC51e77091-b6ab-45e7-9be5-fc3a3e894bbb2025-11-21WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Cherry ColaALCOHOLI World LLC4420574a-bc9b-a5aa-e063-6394a90a577f2025-11-21WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer lavender aloeETHYL ALCOHOLEO Products, LLCecfcf690-5ce8-4827-b13e-f09fd04a046b2025-11-21WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes ruby grapefruitETHYL ALCOHOLEO Products, LLC35a95320-10c9-403c-81d3-17b47954e3a92025-11-21WarningsExact identifier
unii: 3K9958V90M
EO HAND SANITIZER LavenderALCOHOLEO Products, LLC36b26803-ed48-498f-bc0e-15473495a35a2025-11-21WarningsExact identifier
unii: 3K9958V90M
Smart Care JASMINE GARDENIA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6fef7c0b-04f8-4c26-95fa-79911d875e182025-11-21WarningsExact identifier
unii: 3K9958V90M
EO HAND SANITIZER LavenderALCOHOLEO Products, LLC4192e27f-0034-4cd9-b9e0-27b52cb4b9702025-11-21WarningsExact identifier
unii: 3K9958V90M
EO HAND SANITIZER UnscentedALCOHOLEO Products, LLC7c2bf597-65f1-44ad-9cfd-05cd7e9973c82025-11-20WarningsExact identifier
unii: 3K9958V90M
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Lavender Hand Sanitizing WipesETHANOLWhole Foods Market, Inc.039edd3c-8ccd-0c6c-e063-6294a90ab9ba2025-11-20WarningsExact identifier
unii: 3K9958V90M
Lavender Hand Sanitizer WipesETHANOLWhole Foods Market, Inc.039dfc12-6088-1b1f-e063-6394a90a7e922025-11-20WarningsExact identifier
unii: 3K9958V90M
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
unii: 3K9958V90M
Plus Brasept Alcocol GelALCOHOLNEWDROP NORTH AMERICA LLCf791c99c-5879-9ba2-e053-6394a90ad3c72025-11-20WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
unii: 3K9958V90M
INSTANT HAND SANITIZER ClassicETHYL ALCOHOLUniversal Distribution Center LLC65faf3d6-4e1c-4092-ac77-f6d77bf49cd62025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer coconut lemonETHYL ALCOHOLEO Products, LLCe42fae4c-4e6e-4309-b6fa-2fbb95c5cbc22025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes lavender aloeETHYL ALCOHOLEO Products, LLC8128b366-c2e3-4ffc-948f-299227a364a12025-11-20WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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