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 84 of 162 · 3,223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: XF417D3PSL
mild iodine tinctureIODINE AND SODIUM IODIDE AND ALCOHOLBIONPHARMA INC.3ed930e0-0e73-277b-e063-6394a90a1b312025-10-06WarningsExact identifier
unii: 3K9958V90M
Purforma Advanced Hand Sanitizer 70% AlcoholHAND SANITIZER 70% ALCOHOLSpartan Chemical Company, Inc.06bd825d-914f-5ca7-e063-6394a90aec492025-10-06WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER SWEET PEONYETHYL ALCOHOLPearl World Inc.d8530009-be78-4a06-851a-f2de0f9b5fdb2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST LAVENDER SCENTETHYL ALCOHOLPearl World Inc.59d76f20-ca26-4cb2-b929-f8ae7c281f3e2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT LIME SCENTETHYL ALCOHOLPearl World Inc.d47930c5-ea4e-43a5-8654-ca4f9d391c2d2025-10-06WarningsExact identifier
unii: 3K9958V90M
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA, Inc.b1c8e5d0-a766-4bf0-a385-b7b8940a0e2c2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.a0df14cd-50a3-48ba-8510-f04276793acc2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST OCEAN BREEZE SCENTETHYL ALCOHOLPearl World Inc.2d37bdef-2927-4d5c-906d-4f6563524cdd2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA SUGAR SCENTETHYL ALCOHOLPearl World Inc.0c5c7939-b2ba-47b6-bb51-39920e320f952025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.fd522416-b585-4426-ac0b-fb363d8ae5922025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SWEET PEONY SCENTETHYL ALCOHOLPearl World Inc.1fbe93d5-8af2-41ca-b516-98729655d2d42025-10-03WarningsExact identifier
unii: 3K9958V90M
Zylast AntisepticETHYL ALCOHOLInnovative BioDefense178190dc-7c68-6485-e054-00144ff8d46c2025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c77ae-e9ff-4656-e053-2995a90a16d42025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand SanitizerALCOHOLInnovative Biodefense, Incd91b6278-864e-477a-e053-2a95a90aabd92025-10-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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