FDA.reportPublic FDA data

XYOSTED

Product NDC
54436-250
11-digit product format
544360250
Labeler code
54436
Product ID
54436-250_c8d74eb6-fa94-446a-8307-091436a536dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone enanthate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Antares Pharma, Inc.
Application
NDA209863
Marketing category
NDA
Marketing start
2018-11-15
Substance
TESTOSTERONE ENANTHATE
Active strength
50 mg/.5mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XYOSTED
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE ENANTHATE50 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7Z6522T8N9
Rxcui2099681, 2099686, 2099689, 2099691, 2099695, 2099697

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
54436-250-01XYOSTED1 in 1 CARTONINJECTION116
54436-250-02XYOSTED0.5 mL in 1 SYRINGEINJECTION0.516
54436-250-03XYOSTED0.5 mL in 1 SYRINGEINJECTION0.516
54436-250-04XYOSTED4 in 1 CARTONINJECTION416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54436-250-02ML - Milliliter54436-2504fa6e167-bb60-4c91-ba1f-c23e58ca513612018-11-06
54436-250-04ML - Milliliter54436-250d8e04683-24c0-4eb4-81f5-3ac2566d728f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54436-250XYOSTED (TESTOSTERONE ENANTHATE) INJECTION [ANTARES PHARMA, INC.]12Current NDC, Legacy NDC, 4 package rows20250406_8a3d204c-be26-49e0-8599-0ac12a272e81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2099681testosterone enanthate 100 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099689testosterone enanthate 50 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099695testosterone enanthate 75 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099686XYOSTED 100 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099691XYOSTED 50 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
2099697XYOSTED 75 MG in 0.5 ML Auto-InjectorPSN8a3d204c-be26-49e0-8599-0ac12a272e8116
20996910.5 ML testosterone enanthate 100 MG/ML Auto-Injector [Xyosted]SBD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996970.5 ML testosterone enanthate 150 MG/ML Auto-Injector [Xyosted]SBD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996860.5 ML testosterone enanthate 200 MG/ML Auto-Injector [Xyosted]SBD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996890.5 ML testosterone enanthate 100 MG/ML Auto-InjectorSCD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996950.5 ML testosterone enanthate 150 MG/ML Auto-InjectorSCD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996810.5 ML testosterone enanthate 200 MG/ML Auto-InjectorSCD8a3d204c-be26-49e0-8599-0ac12a272e8116
20996910.5 ML Xyosted 100 MG/ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
20996970.5 ML Xyosted 150 MG/ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
20996860.5 ML Xyosted 200 MG/ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099681testosterone enanthate 100 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099689testosterone enanthate 50 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099695testosterone enanthate 75 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099686Xyosted 100 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099691Xyosted 50 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116
2099697XYOSTED 75 MG per 0.5 ML Auto-InjectorSY8a3d204c-be26-49e0-8599-0ac12a272e8116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54436-250-01544360250011 SYRINGE in 1 CARTON (54436-250-01) / .5 mL in 1 SYRINGE (54436-250-03) 1 syringe2018-11-150000-00-00YesNoCurrent
54436-250-02544360250020.5 mL in 1 SYRINGE0.5 mlHistorical
54436-250-03544360250030.5 mL in 1 SYRINGE0.5 mlHistorical
54436-250-04544360250044 SYRINGE in 1 CARTON (54436-250-04) / .5 mL in 1 SYRINGE (54436-250-02) 4 syringe2018-11-150000-00-00NoNoCurrent