FDA.reportPublic FDA data

AMIODARONE HYDROCHLORIDE

Substance profile for UNII 976728SY6Z, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for AMIODARONE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Substance Identity#

UNII
976728SY6Z
Preferred term
AMIODARONE HYDROCHLORIDE
Registry number
19774-82-4
EC number
243-293-2
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C25H29I2NO3.ClH
Chemical structure for AMIODARONE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Chemical And Database Identifiers#

InChIKey
ITPDYQOUSLNIHG-UHFFFAOYSA-N
SMILES
Cl.CCCCC1=C(C(=O)C2=CC(I)=C(OCCN(CC)CC)C(I)=C2)C3=C(O1)C=CC=C3
RxCUI
203114
PubChem
0
NCIt
C236
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem InChIKey SearchITPDYQOUSLNIHG-UHFFFAOYSA-Npubchem.ncbi.nlm.nih.gov/#query=ITPDYQOUSLNIHG-UHFFFAOYSA-N
RxNorm203114mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=203114
NCI ThesaurusC236ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C236
FDA Substance Registration System976728SY6Zprecision.fda.gov/uniisearch/srs/unii/976728SY6Z
European Community number243-293-2commonchemistry.cas.org/results?q=243-293-2

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
Amiodarone Hydrochloride Tablets1
Amiodarone HCl 450 mg Added to 5% Dextrose 250 mL Bag8
Amiodarone HCl 900 mg Added to 5% Dextrose 500 mL Bag5
These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl Injection for intravenous use Initial U.S. Approval: 19851
These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl injection for intravenous use Initial U.S. Approval: 19851
Amiodarone Hydrochloride Tablets1
PACERONE ® (Amiodarone HCl) Tablets, 100 mg and 200 mg1
Amiodarone Hydrochloride Tablets1
PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]25
AMIODARONE HYDROCHLORIDE TABLET [EON LABS, INC.]24
CORDARONE (AMIODARONE HYDROCHLORIDE) TABLET [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
AMIODARONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]11
AMIODARONE HCL (AMIODARONE HYDROCHLORIDE) TABLET [LIBERTAS PHARMA, INC.]10
AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]9
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]8
AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMIODARONE HYDROCHLORIDE TABLET [APOTEX CORP]6
AMIODARONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]5
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC.]4
AMIODARONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]4
AMIODARONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
AMIODARONE HYDROCHLORIDE TABLET [MCKESSON PACKAGING A BUSINESS UNIT OF MCKESSON CORPORATION]3
AMIODARONE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]3
PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED]2
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2
AMIODARONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]2
AMIODARONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]2
PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]2
AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE) TABLET [ALPHAPHARM PTY LTD]1
AMIODARONE HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT USA LLC.]1
AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT USA LLC.]1
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]1
AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [REMEDYREPACK INC. ]1
AMIODARONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
AMIODARONE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
AMIODARONE HYDROCHLORIDE TABLET [MCKESSON CONTRACT PACKAGING]1
AMIODARONE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]1
AMIODARONE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]1
PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [RXPAK DIVISION OF MCKESSON CORPORATION]1