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 3 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.337c5695-e3f8-41c6-a088-a492d5c602152026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDECardinal Health 107, LLC7bdc2236-3a1a-4210-a9fb-38f860227aa72026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEMajor Pharmaceuticals352ed423-fc16-47bb-8e25-98e1c20f99912026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.7ccd3733-c3af-4a11-8500-0f99194c14722026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAurobindo Pharma Limited7ae393d1-7469-432a-9f21-f5ebab1207d12026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEREMEDYREPACK INC.e9151c1b-b70c-477b-868a-fffdc5c518302026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 1663224
unii: 976728SY6Z
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEZhejiang Poly Pharm. Co., Ltd.0a28ae25-7cc4-4ac0-a2ba-7820fb93e25c2026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 1663248
rxcui: 1663244
rxcui: 1663224
unii: 976728SY6Z
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Amiodarone HydrochlorideAMIODARONE HYDROCHLORIDEAvPAK924c9359-ebc4-62a7-e053-2a95a90a43272026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 976728SY6Z
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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