FDA.reportPublic FDA data

NDC 0641-6184-01 - Digoxin

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
0641-6184
Requested NDC
0641-6184-01
Package NDCs from labels
0641-6184-01, 0641-6184-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2026-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Digoxin - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2026-03-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6184-01Digoxin2 mL in 1 AMPULEINJECTION210
0641-6184-25Digoxin25 in 1 CARTONINJECTION2510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6184DIGOXIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250327_9b9a4b3c-5f08-475a-a74d-0c7ebba40644.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1

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 20 of 163 · 3,246 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Moisturizing Hand Sanitizer Fresh RainfallALCOHOLBath & Body Works, Inc.552faf37-a7ff-df22-e063-6394a90a47cb2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Sparkling WatermelonALCOHOLBath & Body Works, Inc.552fe62e-5e14-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Warm Vanilla SugarALCOHOLBath & Body Works, Inc.552fbc11-1720-fe10-e063-6294a90ac2362026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Champagne ToastALCOHOLBath & Body Works, Inc.552fc4da-f24c-e88a-e063-6394a90ae2ab2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Eucalyptus MintALCOHOLBath & Body Works, Inc.552fc8da-e38a-0dc5-e063-6294a90a9c0c2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mango Papaya ParadiseALCOHOLBath & Body Works, Inc.552fe73b-38de-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Strawberry Peach SunsetALCOHOLBath & Body Works, Inc.552fe62e-5e13-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White Tea and SageALCOHOLBath & Body Works, Inc.552fed13-f320-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.552feb22-c355-0572-e063-6394a90afa8c2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.552fccdd-93c4-efff-e063-6294a90a54ba2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberry TangerineALCOHOLBath & Body Works, Inc.552fe6d9-335d-0842-e063-6394a90a98452026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Marine Waves and CitrusALCOHOLBath & Body Works, Inc.552fe62e-5e18-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Watermelon LemonadeALCOHOLBath & Body Works, Inc.552fe6d9-335f-0842-e063-6394a90a98452026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Turquoise WatersALCOHOLBath & Body Works, Inc.552fe62e-5e1e-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus RainALCOHOLBath & Body Works, Inc.552ff8dc-b386-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Waikiki Beach CoconutALCOHOLBath & Body Works, Inc.552fe62e-5e1d-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Pineapple SunriseALCOHOLBath & Body Works, Inc.552fed13-f326-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Coconut Pina ColadaALCOHOLBath & Body Works, Inc.552fe733-25f7-30a7-e063-6294a90a44642026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.552fed13-f323-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Firecracker PopALCOHOLBath & Body Works, Inc.552ff8dc-b388-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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