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 80 of 153 · 3,046 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
North Woods Derma Gel ClearALCOHOLSuperior Chemical Corporationabbd099a-8d89-80a0-e053-2a95a90a24fc2025-10-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
unii: 3K9958V90M
Novo Foaming Instant Hand SanitizerETHYL ALCOHOLNoble Chemical Inc.0f126636-9606-3aea-e063-6294a90ae3c62025-10-08WarningsExact identifier
unii: 3K9958V90M
Reddy Lab Advanced Alcohol Gel SanitizerALCOHOLFlavor Reddy Foods, LLCb9f76aec-d052-69d2-e053-2995a90a277f2025-10-08WarningsExact identifier
unii: 3K9958V90M
MediChoice Instant Hand Sanitizer Honey scentedALCOHOLO&M HALYARD, INC.531dcfea-09d6-40d6-93e1-65dc4c79709d2025-10-08WarningsExact identifier
unii: 3K9958V90M
MediChoice Instant Hand Sanitizer Fragrance freeALCOHOLO&M HALYARD, INC.c9cd6726-8a3a-429e-bef4-e0614b7540eb2025-10-08WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand RubALCOHOLO&M HALYARD, INC.61dbc28c-6011-44a8-983d-0f6f2fe8d7622025-10-08WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER SWEET STRAWBERRYETHYL ALCOHOLPearl World Inc.cf4f279d-d61c-43c7-a6f0-fe1aeac9c0762025-10-07WarningsExact identifier
unii: 3K9958V90M
LOCKE TEDDYALCOHOL ANTISEPTICKINGKEY MBC LIFE TECHNOLOGY GROUP CO.,LTD7c0056c1-3add-49f6-8816-b61a7f5a05082025-10-07WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCHOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD66c18336-ff38-49b1-b513-2413526247472025-10-07WarningsExact identifier
unii: 3K9958V90M
Clean Simple Hand SanitizerALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD1524c380-9a4a-4203-9901-2731004487a02025-10-07WarningsExact identifier
unii: 3K9958V90M
Pure care hand sanitizerALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD26b8c4f7-6c31-42dc-8066-e733eadab1902025-10-07WarningsExact identifier
unii: 3K9958V90M
livWellALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD532225d0-7c9d-4043-a274-7dd7fea116622025-10-07WarningsExact identifier
unii: 3K9958V90M
Locke TeddyALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDfc1c8922-36a0-4150-ab32-f01f1f5466002025-10-07WarningsExact identifier
unii: 3K9958V90M
Anthem Hand SanitizerALCOHOLKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDf1755c79-bce1-4e2a-8c4c-29271581c1d02025-10-07WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST WATERMELON SCENTETHYL ALCOHOLPearl World Inc.e9a1e22c-5c90-4454-af86-7885f66bb5f22025-10-07WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLPearl World Inc.88476764-a1a1-4724-a371-b5fb2d1286e92025-10-07WarningsExact identifier
unii: 3K9958V90M
Alcare Plus Foaming Antiseptic HandrubALCOHOLSC Johnson Professional USA Incb8071505-9046-4780-bd65-705797a89f2a2025-10-06WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER SUGAR VANILLAETHYL ALCOHOLPearl World Inc.d29b8d41-acae-41f5-9d2c-9c06e3c166282025-10-06WarningsExact identifier
unii: 3K9958V90M
mild iodine tinctureIODINE AND SODIUM IODIDE AND ALCOHOLBIONPHARMA INC.3ed930e0-0e73-277b-e063-6394a90a1b312025-10-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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