FDA.reportPublic FDA data

Kyzatrex

Product NDC
80603-105
11-digit product format
806030105
Labeler code
80603
Product ID
80603-105_413922db-74d9-ab1f-e063-6394a90aba28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TESTOSTERONE UNDECANOATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Marius Pharmaceuticals
Application
NDA213953
Marketing category
NDA
Marketing start
2022-07-27
Substance
TESTOSTERONE UNDECANOATE
Active strength
200 mg/1
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kyzatrex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE UNDECANOATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH16A5VCT9C
Rxcui2609597, 2609603, 2609605, 2609607, 2609609, 2609611

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80603-105-11Kyzatrex90 in 1 BOTTLECAPSULE, LIQUID FILLED9022
80603-105-22Kyzatrex120 in 1 BOTTLECAPSULE, LIQUID FILLED12022
80603-105-33Kyzatrex60 in 1 BOTTLECAPSULE, LIQUID FILLED6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80603-105-22EA - Each80603-105e79b66ab-47d3-4286-9c9e-2892a6120c4212022-11-07
80603-105-33EA - Each80603-105b28ee14a-5c0d-4120-b832-e1f41f93eac112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80603-105KYZATREX (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [MARIUS PHARMACEUTICALS]15Current NDC, Legacy NDC, 3 package rows20231027_7f7167a7-2a25-47e2-acf5-33f499fce971.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2609603KYZATREX 100 MG Oral CapsulePSN7f7167a7-2a25-47e2-acf5-33f499fce97122
2609607KYZATREX 150 MG Oral CapsulePSN7f7167a7-2a25-47e2-acf5-33f499fce97122
2609611KYZATREX 200 MG Oral CapsulePSN7f7167a7-2a25-47e2-acf5-33f499fce97122
2609597testosterone undecanoate 100 MG Oral CapsulePSN7f7167a7-2a25-47e2-acf5-33f499fce97122
2609605testosterone undecanoate 150 MG Oral CapsulePSN7f7167a7-2a25-47e2-acf5-33f499fce97122
2609609testosterone undecanoate 200 MG Oral CapsulePSN7f7167a7-2a25-47e2-acf5-33f499fce97122
2609603testosterone undecanoate 100 MG Oral Capsule [Kyzatrex]SBD7f7167a7-2a25-47e2-acf5-33f499fce97122
2609607testosterone undecanoate 150 MG Oral Capsule [Kyzatrex]SBD7f7167a7-2a25-47e2-acf5-33f499fce97122
2609611testosterone undecanoate 200 MG Oral Capsule [Kyzatrex]SBD7f7167a7-2a25-47e2-acf5-33f499fce97122
2609597testosterone undecanoate 100 MG Oral CapsuleSCD7f7167a7-2a25-47e2-acf5-33f499fce97122
2609605testosterone undecanoate 150 MG Oral CapsuleSCD7f7167a7-2a25-47e2-acf5-33f499fce97122
2609609testosterone undecanoate 200 MG Oral CapsuleSCD7f7167a7-2a25-47e2-acf5-33f499fce97122
2609603Kyzatrex 100 MG Oral CapsuleSY7f7167a7-2a25-47e2-acf5-33f499fce97122
2609607Kyzatrex 150 MG Oral CapsuleSY7f7167a7-2a25-47e2-acf5-33f499fce97122
2609611Kyzatrex 200 MG Oral CapsuleSY7f7167a7-2a25-47e2-acf5-33f499fce97122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80603-105-118060301051190 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-11) 2022-07-270000-00-00NoNoCurrent
80603-105-2280603010522120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-22) 2022-07-270000-00-00NoNoCurrent
80603-105-338060301053360 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-33) 2023-09-25NoNoHistorical