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 21 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Neapolitan Ice CreamALCOHOLBath & Body Works, Inc.552ff8dc-b38a-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.552fe6d9-3364-0842-e063-6394a90a98452026-06-26WarningsExact identifier
unii: 3K9958V90M
Iced Lemon Pound Cake Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.552fe73b-38dc-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cozy Vanilla AlmondALCOHOLBath & Body Works, Inc.55300198-e9c1-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pina Colada SwirlALCOHOLBath & Body Works, Inc.552ffde3-ccce-2ffd-e063-6394a90a08402026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.55300198-e9bc-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.552ffc4e-aded-ff0e-e063-6294a90abdc02026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Wildberry French ToastALCOHOLBath & Body Works, Inc.552ff81f-28da-0f6e-e063-6394a90ab5832026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cotton Candy CobwebsALCOHOLBath & Body Works, Inc.5530026f-04cf-471f-e063-6294a90a165e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.552fe73b-38e1-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vampire BloodALCOHOLBath & Body Works, Inc.55300198-e9be-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
serendipity3 Hand Sanitizer Vanilla Ice Cream ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO849d99f7-2890-42b4-84ab-99ef811641d52026-06-26WarningsExact identifier
unii: 3K9958V90M
AURA LANE HAND SANITIZER CHERRY BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO1f613b11-9dbd-4beb-9211-9d1fa3b2d7d92026-06-25WarningsExact identifier
unii: 3K9958V90M
Extended Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.363cd347-d25e-42b9-9ce7-30642f3cb3532026-06-25Warnings, Adverse reactionsExact identifier
unii: 4182431BJH
SOUR LEMON HAND SANITIZER WHITE PEACH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOddb9bf98-f94c-4306-a8b4-c711e926b6322026-06-25WarningsExact identifier
unii: 3K9958V90M
serendipity3 HAND SANITIZER Vanilla Honey SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2720c07c-e457-4377-b098-31c61c62e0122026-06-25WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER VANILLA BEAN SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2291c8b2-2ea7-4e64-91ac-ced8f8b03f402026-06-25WarningsExact identifier
unii: 3K9958V90M
serendipity3 Hand Sanitizer Butter Croissant ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO91a99a2c-0271-451b-b201-f369bca3da112026-06-25WarningsExact identifier
unii: 3K9958V90M
serendipity3 HAND SANITIZER Butter Chiffon SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO7a0b2137-6114-4333-b2d7-2df078ade44a2026-06-24WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER FRESH WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOd47ab0e7-fb96-4116-b927-67a681e152ca2026-06-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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