FDA.reportPublic FDA data

NDC 65219-643-01 - Amiodarone Hydrochloride

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
65219-643
Requested NDC
65219-643-01
Package NDCs from labels
65219-643-01, 65219-643-03
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amiodarone Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-03-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-643-01Amiodarone Hydrochloride3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION31
65219-643-03Amiodarone Hydrochloride25 in 1 TRAYINJECTION, SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-643AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20250506_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a.zip

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 5 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAmerican Health Packagingd912a75a-ddac-4e7b-b5c4-321d4252ec052025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
PaceroneAMIODARONE HYDROCHLORIDEBryant Ranch Prepackdcadce9c-d0a0-4235-8ff8-dd93c09e03b32025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDEHenry Schein, Inc.0c9ee15a-5741-4aaa-8d80-c7bd2e45822e2025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMedical Purchasing Solutions, LLC.4240b2e9-be05-3de5-e063-6394a90a4bb22025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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