FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
72162-1119
11-digit product format
721621119
Labeler code
72162
Product ID
72162-1119_e0dbacaf-d2e7-4044-a9a6-def2313e1912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Bryant Ranch Prepack
Application
ANDA091244
Marketing category
ANDA
Marketing start
2014-05-01
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
Rxcui2047882

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
72162-1119-2Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION1100
72162-1119-2Testosterone Cypionate1 mL in 1 VIAL, GLASSINJECTION, SOLUTION1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1119-2ML - Milliliter72162-1119cf845b65-1798-42d0-82b3-0ee8c17ebd7a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1119TESTOSTERONE CYPIONATE INJECTION, SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250406_327b4357-6948-4cd6-ad6c-e463ab8600ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN327b4357-6948-4cd6-ad6c-e463ab8600ad100
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD327b4357-6948-4cd6-ad6c-e463ab8600ad100
2047882testosterone cypionate 200 MG per 1 ML InjectionSY327b4357-6948-4cd6-ad6c-e463ab8600ad100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1119-2721621119021 VIAL, GLASS in 1 CARTON (72162-1119-2) / 1 mL in 1 VIAL, GLASS2025-04-02NoNoCurrent