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 60 of 153 · 3,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
unii: 3K9958V90M
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Instant Hand Sanitizer UnscentedALCOHOLHu-Friedy Mfg. Co., Inc.1811a5d8-8a08-4a40-88e2-f86e822e610d2026-01-08WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer CitrusALCOHOLSoapbox Soaps LLC3a08a336-aac1-4b6e-acc5-799330e4dcfc2026-01-08WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLNew World Imports, Inc.29d8c137-9a55-4e37-bdec-bdf48a7d39ed2026-01-08WarningsExact identifier
unii: 3K9958V90M
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Avagard DALCOHOLSolventum US LLC00c56d8d-02e6-4839-86cc-00767428d5e92026-01-08WarningsExact identifier
unii: 3K9958V90M
EcoChoice Sterno Hand Sanitizer Lemon ZestALCOHOLSTERNO PRODUCTS, LLC576b7579-f44d-4315-a9c6-09d9a6d3f61d2026-01-07WarningsExact identifier
unii: 3K9958V90M
EcoChoice Sterno Hand Sanitizer Clean and FreshALCOHOLSTERNO PRODUCTS, LLC6647babe-1d1a-4a23-9042-66d950355c812026-01-07WarningsExact identifier
unii: 3K9958V90M
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER VANILLAETHYL ALCOHOLRejoice International Corp.47c3c187-da54-7c3b-e063-6294a90af3ce2026-01-06WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER CHAMPAGNE BLASHETHYL ALCOHOLRejoice International Corp.47c5e9af-4ea8-fb39-e063-6394a90aa5ab2026-01-06WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLBPI Labs, LLC314b1dab-8f4f-49ae-a105-f974842818b82026-01-05Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand Sanitizing WipesHAND SANITIZING WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD37487da6-4e0e-6625-e063-6394a90a0af12026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Vanilla HeavenALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a0781b-9b25-f04b-e063-6294a90ae7e52026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a16397-dff3-7d79-e063-6394a90a040f2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.74176b95-7899-47c7-a330-87f603aa12f52026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFOURSTAR GROUP USA, INC.437cb27e-4a42-4f36-ae0a-9e456055a1832026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedALCOHOLFourstar Group USA, Inc.4e256c4a-6b58-4011-80f5-51d7527943de2026-01-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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