FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
55150-278
11-digit product format
551500278
Labeler code
55150
Product ID
55150-278_b622f795-00fa-48e3-8e4d-679c2ce28c6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Eugia US LLC
Application
ANDA211817
Marketing category
ANDA
Marketing start
2023-10-20
Substance
TESTOSTERONE CYPIONATE
Active strength
2000 mg/10mL
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
Testosterone Cypionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE2000 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM0XW1UBI14
Rxcui835829, 835840, 2047882

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
55150-278-01Testosterone Cypionate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION103
55150-278-01Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-278TESTOSTERONE CYPIONATE INJECTION, SOLUTION [EUGIA US LLC]2Current NDC, 2 package rows20250322_f901e2b2-f143-4237-8e95-0d134585490b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835829testosterone cypionate 100 MG/ML Injectable SolutionPSNf901e2b2-f143-4237-8e95-0d134585490b3
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNf901e2b2-f143-4237-8e95-0d134585490b3
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNf901e2b2-f143-4237-8e95-0d134585490b3
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDf901e2b2-f143-4237-8e95-0d134585490b3
835829testosterone cypionate 100 MG/ML Injectable SolutionSCDf901e2b2-f143-4237-8e95-0d134585490b3
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDf901e2b2-f143-4237-8e95-0d134585490b3
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSYf901e2b2-f143-4237-8e95-0d134585490b3
2047882testosterone cypionate 200 MG per 1 ML InjectionSYf901e2b2-f143-4237-8e95-0d134585490b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55150-278-01551500278011 VIAL, MULTI-DOSE in 1 CARTON (55150-278-01) / 10 mL in 1 VIAL, MULTI-DOSE2023-10-20NoNoCurrent