FDA.reportPublic FDA data

VARDENAFIL HYDROCHLORIDE

Substance profile for UNII 5M8S2CU0TS, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for VARDENAFIL HYDROCHLORIDE
Structure render from PubChem CID 6918463

Substance Identity#

UNII
5M8S2CU0TS
Preferred term
VARDENAFIL HYDROCHLORIDE
Registry number
330808-88-3
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C23H32N6O4S.ClH.3H2O
Chemical structure for VARDENAFIL HYDROCHLORIDE
Structure render from PubChem CID 6918463

Chemical And Database Identifiers#

InChIKey
FBCDRHDULQYRTB-UHFFFAOYSA-N
SMILES
O.O.O.Cl.CCCC1=NC(C)=C2N1NC(=NC2=O)C3=C(OCC)C=CC(=C3)S(=O)(=O)N4CCN(CC)CC4
RxCUI
307306
PubChem
6918463
NCIt
C76318
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound6918463https://pubchem.ncbi.nlm.nih.gov/compound/6918463
PubChem InChIKey SearchFBCDRHDULQYRTB-UHFFFAOYSA-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=FBCDRHDULQYRTB-UHFFFAOYSA-N
RxNorm307306https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=307306
NCI ThesaurusC76318https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C76318
FDA Substance Registration System5M8S2CU0TShttps://precision.fda.gov/uniisearch/srs/unii/5M8S2CU0TS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSThese highlights do not include all the information needed to use Staxyn safely and effectively. See full prescribing information for Staxyn. STAXYN (vardenafil hydrochloride) orally disintegrating tablets Initial U.S. Approval: 20033
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSVardenafil HCl (Levitra ® ) Tablets1
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSVardenafil HCl (Levitra ® ) 5mg Tablets Rx Only1
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSVardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only1
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSLEVITRA ® (vardenafil HCl) TABLETS1
VARDENAFIL HYDROCHLORIDE TRIHYDRATEACTIVE INGREDIENT5M8S2CU0TSLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
VARDENAFIL HYDROCHLORIDE TRIHYDRATEACTIVE INGREDIENT5M8S2CU0TSLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]6
VARDENAFIL HYDROCHLORIDE TRIHYDRATEACTIVE INGREDIENT5M8S2CU0TSSTAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]5
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [KAISER FOUNDATION HOSPITALS]2
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]1