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 70 of 162 · 3,223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLSolupharm Pharmazeutische Erzeugnisse GmbH372d3eb5-78ee-414c-a146-4a19e22661842025-12-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
Kay Hand Sanitizer FoamETHYL ALCOHOLEcolab Inc.f82eaaaf-cead-497a-8b95-9668310511872025-12-17WarningsExact identifier
unii: 3K9958V90M
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
Keystone Liquid Hand SanitizerALCOHOLEcolab Inc.1d808912-f1ad-4eed-a52d-6c6a363ddba22025-12-16WarningsExact identifier
unii: 3K9958V90M
EcolabALCOHOLEcolab Inc.69962e54-2e1f-404a-b039-5ebf77cabd5f2025-12-16WarningsExact identifier
unii: 3K9958V90M
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
unii: 3K9958V90M
ORBIT INNOVATIONS HAND SANITIZERALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd1abf5aca-346f-0d18-e063-6294a90a93392025-12-11WarningsExact identifier
unii: 3K9958V90M
Dial Professional Gel SanitizerDIAL PROFESSIONAL GEL HAND SANITIZERHenkel Corporation28dadc94-e802-9fbb-e063-6394a90a79982025-12-11WarningsExact identifier
unii: 3K9958V90M
DigoxinDIGOXINProPharma Distribution45b0d1e0-d1f6-28f6-e063-6394a90aaa512025-12-11Warnings, Adverse reactionsExact identifier
application number: ANDA083391
rxcui: 104208
unii: 73K4184T59
DigoxinDIGOXINAtlantic Biologicals Corpsdcf907d9-0f0e-4ecc-a555-7e6dcc08c1662025-12-11Warnings, Adverse reactionsExact identifier
unii: 73K4184T59
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
unii: 3K9958V90M
B Pure Hand Sanitizer Tropical Burst ScentedALCOHOLFourstar Group USA, Inc.90c59897-ae56-4c5f-a0da-ced827e63eb02025-12-10WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Blossom Dream Scented Limited EditionALCOHOLFourstar Group USA, Inc.86c8b44e-a03b-4e58-913c-74a064a42eae2025-12-10WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Coconut Praline Scented Limited EditionALCOHOLFourstar Group USA, Inc.64ea1fcf-026b-4179-8a9d-219818e00e4a2025-12-10WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Guava Nectar Scented Limited EditionALCOHOLFourstar Group USA, Inc.29c9ea5e-f525-4107-98c0-9697ba9106ac2025-12-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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