FDA.reportPublic FDA data

Jatenzo

Product NDC
69087-198
11-digit product format
690870198
Labeler code
69087
Product ID
69087-198_b62fac0e-07df-453f-b56a-bd94e5ee3336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone undecanoate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOLMAR Inc.
Application
NDA206089
Marketing category
NDA
Marketing start
2019-08-01
Substance
TESTOSTERONE UNDECANOATE
Active strength
198 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
Jatenzo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE UNDECANOATE198 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH16A5VCT9C
Rxcui2121766, 2121768, 2121770, 2121776, 2201640, 2201642

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
69087-198-12Jatenzo12 in 1 BOXCAPSULE, LIQUID FILLED1212
69087-198-12Jatenzo120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED12012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69087-198JATENZO (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [TOLMAR INC.]8Current NDC, Legacy NDC, 2 package rows20250522_ed7b5d41-7475-4c10-99b9-b62b3434ae60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2201640JATENZO 158 MG Oral CapsulePSNed7b5d41-7475-4c10-99b9-b62b3434ae6012
2201642JATENZO 198 MG Oral CapsulePSNed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121776JATENZO 237 MG Oral CapsulePSNed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121766testosterone undecanoate 158 MG Oral CapsulePSNed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121768testosterone undecanoate 198 MG Oral CapsulePSNed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121770testosterone undecanoate 237 MG Oral CapsulePSNed7b5d41-7475-4c10-99b9-b62b3434ae6012
2201640testosterone undecanoate 158 MG Oral Capsule [Jatenzo]SBDed7b5d41-7475-4c10-99b9-b62b3434ae6012
2201642testosterone undecanoate 198 MG Oral Capsule [Jatenzo]SBDed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121776testosterone undecanoate 237 MG Oral Capsule [Jatenzo]SBDed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121766testosterone undecanoate 158 MG Oral CapsuleSCDed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121768testosterone undecanoate 198 MG Oral CapsuleSCDed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121770testosterone undecanoate 237 MG Oral CapsuleSCDed7b5d41-7475-4c10-99b9-b62b3434ae6012
2201640Jatenzo 158 MG Oral CapsuleSYed7b5d41-7475-4c10-99b9-b62b3434ae6012
2201642Jatenzo 198 MG Oral CapsuleSYed7b5d41-7475-4c10-99b9-b62b3434ae6012
2121776Jatenzo 237 MG Oral CapsuleSYed7b5d41-7475-4c10-99b9-b62b3434ae6012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69087-198-126908701981212 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-08-010000-00-00NoNoCurrent