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 88 of 153 · 3,043 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f8420-9673-6f77-e063-6294a90a81e42025-08-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3af609-d342-449a-e063-6294a90a0a192025-08-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3bd802-56de-ebcd-e063-6294a90aca152025-08-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Wild RoseALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3c78f6-e6cb-e456-e063-6394a90ac5b82025-08-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c4bceac-21bc-486e-e063-6394a90a0f372025-08-13WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c25e093-0335-fa1d-e063-6394a90ae6842025-08-12WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c266de8-0551-374c-e063-6394a90ab9f42025-08-12WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c236c0b-fccd-6992-e063-6294a90a37ce2025-08-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c2322e0-90d5-6ce6-e063-6394a90ac8bb2025-08-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c23d45e-9050-5b9e-e063-6294a90abd4a2025-08-11WarningsExact identifier
unii: 3K9958V90M
Smart Care CHAMPAGNE TOAST HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.76190577-c74e-4671-8abe-3f158ce662f02025-08-11WarningsExact identifier
unii: 3K9958V90M
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Aruba Aloe Hand SanitizerALCOHOLAruba Aloe Balm NV3bc6d696-43d2-9516-e063-6294a90ae82b2025-08-07WarningsExact identifier
unii: 3K9958V90M
365 Whole Foods Market Refreshing Hand Sanitizer Citrus SunshineETHYL ALCOHOLWhole Foods Market, Inc.3bcf1071-2308-b989-e063-6294a90a68232025-08-07WarningsExact identifier
unii: 3K9958V90M
Purehold Antiseptic Instant Hand SanitizerETHYL ALCOHOL, ISOPROPYL ALCOHOLPure Hold Ltd23e8f582-f436-4c73-a2b1-189da83897ff2025-08-07WarningsExact identifier
unii: 3K9958V90M
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Smart Care OCEAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e0a97dca-c0d0-4914-b570-0ac169bd78022025-08-01WarningsExact identifier
unii: 3K9958V90M
EcolabALCOHOLEcolab Inc.f2f922f0-afd3-40e0-ba6d-6b75159db6402025-07-31WarningsExact identifier
unii: 3K9958V90M
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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