FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
52536-625
11-digit product format
525360625
Labeler code
52536
Product ID
52536-625_3ab32628-1fbc-e980-e063-6394a90a81c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Wilshire Pharmaceuticals
Application
ANDA206368
Marketing category
ANDA
Marketing start
2019-05-31
Substance
TESTOSTERONE CYPIONATE
Active strength
200 mg/mL
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 CYPIONATE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM0XW1UBI14
Rxcui835840, 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52536-625-01Testosterone Cypionate1 mL in 1 VIAL, SINGLE-DOSEINJECTION15
52536-625-01Testosterone Cypionate1 in 1 CARTONINJECTION15
52536-625-10Testosterone Cypionate10 mL in 1 VIAL, MULTI-DOSEINJECTION105
52536-625-10Testosterone Cypionate1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-625-01ML - Milliliter52536-6250a100ef1-288d-4c12-9835-b392c20c082412019-08-06
52536-625-10ML - Milliliter52536-6255a4e7a06-1be9-464a-822c-cfc1471f4d2512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-625TESTOSTERONE CYPIONATE INJECTION [WILSHIRE PHARMACEUTICALS]4Current NDC, Legacy NDC, 4 package rows20241215_58ff6e0d-cc0a-4455-8254-d883d26a3b6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN58ff6e0d-cc0a-4455-8254-d883d26a3b6d5
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN58ff6e0d-cc0a-4455-8254-d883d26a3b6d5
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD58ff6e0d-cc0a-4455-8254-d883d26a3b6d5
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD58ff6e0d-cc0a-4455-8254-d883d26a3b6d5
2047882testosterone cypionate 200 MG per 1 ML InjectionSY58ff6e0d-cc0a-4455-8254-d883d26a3b6d5
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN5fb0c403-3065-498e-b910-c5988269301a4
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD5fb0c403-3065-498e-b910-c5988269301a4
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN5a0bba6a-e8da-4b12-af63-eb27b1cca9e62
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN66d4ae28-97c2-42cc-ab5a-a765a623c9442
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD5a0bba6a-e8da-4b12-af63-eb27b1cca9e62
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD66d4ae28-97c2-42cc-ab5a-a765a623c9442
2047882testosterone cypionate 200 MG per 1 ML InjectionSY5a0bba6a-e8da-4b12-af63-eb27b1cca9e62
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN30b453b9-25ef-8262-e063-6394a90a24c21
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD30b453b9-25ef-8262-e063-6394a90a24c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52536-625-01525360625011 VIAL, SINGLE-DOSE in 1 CARTON (52536-625-01) / 1 mL in 1 VIAL, SINGLE-DOSE2019-05-310000-00-00NoNoCurrent
52536-625-10525360625101 VIAL, MULTI-DOSE in 1 CARTON (52536-625-10) / 10 mL in 1 VIAL, MULTI-DOSE2019-05-310000-00-00NoNoCurrent