Kyzatrex
These highlights do not include all the information needed to use KYZATREX™ safely and effectively. See full prescribing information for KYZATREX™. KYZATREX™ (testosterone undecanoate) capsules, for oral use, CIII Initial U.S. approval: 1953
Approved
Approval ID
7f7167a7-2a25-47e2-acf5-33f499fce971
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
Marius Pharmaceuticals
DUNS: 080572348
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TESTOSTERONE UNDECANOATE
PRODUCT DETAILS
NDC Product Code80603-105
Application NumberNDA213953
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 26, 2023
Generic NameTESTOSTERONE UNDECANOATE
INGREDIENTS (9)
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
PROPYLENE GLYCOL MONOLAURATEInactive
Code: 668Z5835Z3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TESTOSTERONE UNDECANOATEActive
Quantity: 200 mg in 1 1
Code: H16A5VCT9C
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TESTOSTERONE UNDECANOATE
PRODUCT DETAILS
NDC Product Code80603-101
Application NumberNDA213953
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 26, 2023
Generic NameTESTOSTERONE UNDECANOATE
INGREDIENTS (9)
PROPYLENE GLYCOL MONOLAURATEInactive
Code: 668Z5835Z3
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TESTOSTERONE UNDECANOATEActive
Quantity: 100 mg in 1 1
Code: H16A5VCT9C
Classification: ACTIB
TESTOSTERONE UNDECANOATE
PRODUCT DETAILS
NDC Product Code80603-103
Application NumberNDA213953
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 26, 2023
Generic NameTESTOSTERONE UNDECANOATE
INGREDIENTS (9)
PROPYLENE GLYCOL MONOLAURATEInactive
Code: 668Z5835Z3
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TESTOSTERONE UNDECANOATEActive
Quantity: 150 mg in 1 1
Code: H16A5VCT9C
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT