FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
62756-015
11-digit product format
627560015
Labeler code
62756
Product ID
62756-015_bf24bb84-d12f-44e7-98bd-46f3aa792bcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA201720
Marketing category
ANDA
Marketing start
2013-06-17
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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-015-40Testosterone Cypionate1 mL in 1 VIALINJECTION, SOLUTION121
62756-015-40Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-015-40ML - Milliliter62756-015ff5bfebe-556a-4332-80ea-9239c71e53a712013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE CYPIONATEACTIVE INGREDIENTM0XW1UBI14TESTOSTERONE CYPIONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]12
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE CYPIONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]12
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTESTOSTERONE CYPIONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]12
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GTESTOSTERONE CYPIONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]12
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTESTOSTERONE CYPIONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-015TESTOSTERONE CYPIONATE INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]20Current NDC, Legacy NDC, 2 package rows20250323_3653a602-4551-4e6c-84a7-31861f5dc482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835829testosterone cypionate 100 MG/ML Injectable SolutionPSN3653a602-4551-4e6c-84a7-31861f5dc48221
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN3653a602-4551-4e6c-84a7-31861f5dc48221
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN3653a602-4551-4e6c-84a7-31861f5dc48221
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD3653a602-4551-4e6c-84a7-31861f5dc48221
835829testosterone cypionate 100 MG/ML Injectable SolutionSCD3653a602-4551-4e6c-84a7-31861f5dc48221
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD3653a602-4551-4e6c-84a7-31861f5dc48221
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSY3653a602-4551-4e6c-84a7-31861f5dc48221
2047882testosterone cypionate 200 MG per 1 ML InjectionSY3653a602-4551-4e6c-84a7-31861f5dc48221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-015-40627560015401 VIAL in 1 CARTON (62756-015-40) / 1 mL in 1 VIAL1 vial2013-06-170000-00-00NoNoCurrent