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#

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 42 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-BacterialHandSpray Cucumber MelonALCOHOLBath & Body Works, Inc.463fa1ef-d40c-d818-e063-6294a90a5e612026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Twisted PeppermintALCOHOLBath & Body Works, Inc.463f5b3a-d693-869c-e063-6394a90ac8d02026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Spring AppleALCOHOLBath & Body Works, Inc.463fcad3-0c5c-599f-e063-6394a90a8d212026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.4650bac0-c64a-f595-e063-6294a90abdf22026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Gingerbread BakeryALCOHOLBath & Body Works, Inc.4690a48e-b80e-cafc-e063-6394a90aa6a12026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cinnamon Sugar Pretzel CookieALCOHOLBath & Body Works, Inc.4691401f-e697-898a-e063-6394a90a8d322026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel To The MoonALCOHOLBath & Body Works, Inc.46914e57-f085-e6cd-e063-6294a90a6fc42026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Winter Candy AppleALCOHOLBath & Body Works, Inc.463f7ab4-e5f3-ab23-e063-6394a90a541b2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Marshmallow Pumpkin LatteALCOHOLBath & Body Works, Inc.4650a56b-c159-b228-e063-6394a90a5a6e2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bright Christmas MorningALCOHOLBath & Body Works, Inc.4650bf54-c759-f503-e063-6294a90a1d2e2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cookie Butter TruffleALCOHOLBath & Body Works, Inc.468c92f6-9cae-0c6e-e063-6394a90a78ef2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mrs. Claus CocktailALCOHOLBath & Body Works, Inc.468c93d1-8265-7cd2-e063-6294a90a57762026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Sparkling SnowALCOHOLBath & Body Works, Inc.468c9682-6163-830f-e063-6294a90a76a92026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray White Tea and SageALCOHOLBath & Body Works, Inc.463fc2a9-742a-fbd3-e063-6394a90a0bf92026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Twisted PeppermintALCOHOLBath & Body Works, Inc.4650b8b0-87be-8c88-e063-6394a90a52ed2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cereal Milk Soft ServeALCOHOLBath & Body Works, Inc.469140f3-24ed-88e5-e063-6394a90a2f512026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Peppermint Bark TruffleALCOHOLBath & Body Works, Inc.469149e2-656a-cb52-e063-6294a90ad50c2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pumpkin AppleALCOHOLBath & Body Works, Inc.4650ae83-ed71-a7aa-e063-6294a90ad1092026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.4650bbda-1646-da3a-e063-6294a90a67fa2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blackberries and BasilALCOHOLBath & Body Works, Inc.4650ab55-8ce4-a5e1-e063-6294a90a79bf2026-03-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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