FDA.reportPublic FDA data

NDC 67457-153-99 - 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
67457-153
Requested NDC
67457-153-99
Package NDCs from labels
67457-153-00, 67457-153-03, 67457-153-99, 67457-153-09, 67457-153-18
Manufacturer
ProPharma Distribution
Effective date
2025-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amiodarone Hydrochloride - ProPharma DistributionProPharma Distribution2025-12-17HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - Henry Schein, IncHenry Schein, Inc2025-09-19HUMAN PRESCRIPTION DRUG LABEL
AMIODARONE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-28HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-15HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-07HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - Mylan Institutional LLCMylan Institutional LLC2020-07-15HUMAN PRESCRIPTION DRUG LABEL
Amiodarone Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-03-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-153-00Amiodarone Hydrochloride3 mL in 1 VIAL, GLASSINJECTION, SOLUTION317
67457-153-03Amiodarone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1017
67457-153-09Amiodarone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1017
67457-153-18Amiodarone Hydrochloride18 mL in 1 VIAL, GLASSINJECTION, SOLUTION1817
67457-153-18Amiodarone Hydrochloride1 in 1 CARTONINJECTION, SOLUTION117
67457-153-99Amiodarone Hydrochloride9 mL in 1 VIAL, GLASSINJECTION, SOLUTION917

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-153AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]17Current NDC, Legacy NDC, 6 package rows20201120_fcc8658c-761a-443f-8c32-1499d86028ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-153-00ML - Milliliter67457-1537168fefb-1564-462c-969e-0394f268239812015-08-04
67457-153-03ML - Milliliter67457-153cded1d68-e294-4516-a049-93e827342fb012012-07-24
67457-153-09ML - Milliliter67457-1536476ab0b-7de7-41bc-af11-09227c7e5a5e12012-07-24
67457-153-18ML - Milliliter67457-1535eaef046-284e-4c97-8f2a-43a438166b4112012-07-24
67457-153-99ML - Milliliter67457-1536d642ff4-c140-4aa8-8b54-24c8a08a186912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8
AmiodaroneACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8
waterINACTIVE INGREDIENT059QF0KO0RAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2
AmiodaroneACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
AmiodaroneACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]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 8 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Amiodarone hydrochlorideAMIODARONE HYDROCHLORIDEZydus Lifesciences Limited3e8db251-e3c5-4fba-be9a-6044a92f0beb2024-11-25Exact identifier
unii: 976728SY6Z
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsd42293e9-07fa-41b4-a08b-2e388f5b1e132024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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