FDA.reportPublic FDA data

Testopel

Product NDC
66887-004
11-digit product format
668870004
Labeler code
66887
Product ID
66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
PELLET
Route
SUBCUTANEOUS
Labeler
Endo USA, Inc.
Application
ANDA080911
Marketing category
ANDA
Marketing start
2014-10-31
Substance
TESTOSTERONE
Active strength
75 mg/1
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
Testopel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui318240, 404405

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
66887-004-01Testopel1 in 1 AMPULEPELLET128
66887-004-10Testopel10 in 1 BOXPELLET1028
66887-004-20Testopel100 in 1 BOXPELLET10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66887-004-01EA - Each66887-0044b7e8575-f737-450c-b87e-33b927a8ddd212016-10-06
66887-004-10EA - Each66887-00407fa8d89-1f93-445d-8ea6-5669efff12a512014-11-05
66887-004-20EA - Each66887-004fed323f9-75ad-4d9b-87f2-c113f384f37c12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTOPEL (TESTOSTERONE) PELLET [AUXILIUM PHARMACEUTICALS, INC.]11
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOPEL (TESTOSTERONE) PELLET [AUXILIUM PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66887-004TESTOPEL (TESTOSTERONE) PELLET [ENDO USA, INC.]24Current NDC, Legacy NDC, 3 package rows20240425_03b9c0b1-5884-11e4-8ed6-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404405TESTOPEL 75 MG Subcutaneous Pellet Drug ImplantPSN03b9c0b1-5884-11e4-8ed6-0800200c9a6628
318240testosterone 75 MG Subcutaneous Pellet Drug ImplantPSN03b9c0b1-5884-11e4-8ed6-0800200c9a6628
404405testosterone 75 MG Drug Implant [Testopel]SBD03b9c0b1-5884-11e4-8ed6-0800200c9a6628
318240testosterone 75 MG Drug ImplantSCD03b9c0b1-5884-11e4-8ed6-0800200c9a6628
404405Testopel 75 MG Drug ImplantSY03b9c0b1-5884-11e4-8ed6-0800200c9a6628
404405Testopel 75 MG Subcutaneous PelletSY03b9c0b1-5884-11e4-8ed6-0800200c9a6628
318240testosterone 75 MG Implant PelletSY03b9c0b1-5884-11e4-8ed6-0800200c9a6628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66887-004-01668870004011 in 1 AMPULEHistorical
66887-004-106688700041010 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01) 10 ampule2014-10-310000-00-00NoNoCurrent
66887-004-2066887000420100 AMPULE in 1 BOX (66887-004-20) / 1 PELLET in 1 AMPULE (66887-004-01) 100 ampule2014-10-310000-00-00NoNoCurrent