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 4 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEBryant Ranch Prepack8377eb89-0d62-48c5-90e7-e96d545a46422025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs28cd0224-3569-4308-bd40-480bc42305032025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEProPharma Distribution364ab45e-b525-f310-e063-6394a90a44212025-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA076217
ndc (package): 84549-153-03
ndc (product): 84549-153
rxcui: 1663224
spl id: 462a9d14-baa5-8d4b-e063-6394a90a0d58
spl set id: 364ab45e-b525-f310-e063-6394a90a4421
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAdvagen Pharma Limitedd911b4cf-eec4-43f8-aa64-cc60cfc901b92025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEChartwell RX, LLC5520f11d-968d-4f4f-bf57-d14369c0d7462025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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