FDA.reportPublic FDA data

Depo-Testosterone

Product NDC
0009-0086
11-digit product format
000090086
Labeler code
0009
Product ID
0009-0086_d47c9c86-9b65-4daa-b5dd-63975d19e154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Pharmacia & Upjohn Company LLC
Application
ANDA085635
Marketing category
ANDA
Marketing start
2014-07-01
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
Depo-Testosterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM0XW1UBI14
Rxcui835829, 835831, 835840, 835842

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
0009-0086-01Depo-Testosterone1 in 1 CARTONINJECTION, SOLUTION116
0009-0086-01Depo-Testosterone1 mL in 1 VIALINJECTION, SOLUTION116
0009-0086-10Depo-Testosterone1 in 1 CARTONINJECTION, SOLUTION116
0009-0086-10Depo-Testosterone10 mL in 1 VIALINJECTION, SOLUTION1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0086-01ML - Milliliter0009-0086abb7df9e-3ce9-41f7-bf64-54864966575b12014-08-01
0009-0086-10ML - Milliliter0009-0086f85153bb-8ade-4868-8a02-9bfc42e9b47e12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE CYPIONATEACTIVE INGREDIENTM0XW1UBI14DEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]5
TESTOSTERONEACTIVE MOIETY3XMK78S47ODEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]5
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GDEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]5
COTTONSEED OILINACTIVE INGREDIENTH3E878020NDEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0086DEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY LLC]14Current NDC, Legacy NDC, 4 package rows20200820_735b5bf3-4464-412c-a072-1bd02f2e5380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835831Depo-Testosterone 100 MG/ML Injectable SolutionPSN735b5bf3-4464-412c-a072-1bd02f2e538016
835842Depo-Testosterone 200 MG/ML Injectable SolutionPSN735b5bf3-4464-412c-a072-1bd02f2e538016
835829testosterone cypionate 100 MG/ML Injectable SolutionPSN735b5bf3-4464-412c-a072-1bd02f2e538016
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN735b5bf3-4464-412c-a072-1bd02f2e538016
835831testosterone cypionate 100 MG/ML Injectable Solution [Depo-testosterone]SBD735b5bf3-4464-412c-a072-1bd02f2e538016
835842testosterone cypionate 200 MG/ML Injectable Solution [Depo-testosterone]SBD735b5bf3-4464-412c-a072-1bd02f2e538016
835829testosterone cypionate 100 MG/ML Injectable SolutionSCD735b5bf3-4464-412c-a072-1bd02f2e538016
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD735b5bf3-4464-412c-a072-1bd02f2e538016
835831Depo-testosterone 100 MG/ML Injectable SolutionSY735b5bf3-4464-412c-a072-1bd02f2e538016
835842Depo-testosterone 200 MG/ML Injectable SolutionSY735b5bf3-4464-412c-a072-1bd02f2e538016
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSY735b5bf3-4464-412c-a072-1bd02f2e538016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0086-01000090086011 VIAL in 1 CARTON (0009-0086-01) / 1 mL in 1 VIAL1 vial2014-07-010000-00-00NoNoCurrent
0009-0086-10000090086101 VIAL in 1 CARTON (0009-0086-10) > 10 mL in 1 VIAL1 vial2014-07-010000-00-00NoNoCurrent