FDA.reportPublic FDA data

Testosterone

Product NDC
0832-1120
11-digit product format
008321120
Labeler code
0832
Product ID
0832-1120_39853cd7-bfd1-848f-e063-6294a90a49e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TOPICAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA204399
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-06-16
Substance
TESTOSTERONE
Active strength
50 mg/5g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE50 mg/5g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1596780, 1597129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
0832-1120-05Testosterone30 in 1 CARTONGEL3013
0832-1120-35Testosterone30 in 1 CARTONGEL3013
0832-1120-65Testosterone5 g in 1 TUBEGEL513
0832-1120-89Testosterone5 g in 1 PACKETGEL513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1120TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, LLC]11Current NDC, Legacy NDC, 4 package rows20230517_a887020f-b41f-49fe-8379-f01147b2a796.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596780testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSNa887020f-b41f-49fe-8379-f01147b2a79613
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSNa887020f-b41f-49fe-8379-f01147b2a79613
15971295000 MG testosterone 0.01 MG/MG Topical GelSCDa887020f-b41f-49fe-8379-f01147b2a79613
159678060 ACTUAT testosterone 12.5 MG/ACTUAT Topical GelSCDa887020f-b41f-49fe-8379-f01147b2a79613
1596780testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUATSYa887020f-b41f-49fe-8379-f01147b2a79613
1597129testosterone 50 MG Transdermal Gel, 5 GMSYa887020f-b41f-49fe-8379-f01147b2a79613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-1120-050083211200530 TUBE in 1 CARTON (0832-1120-05) / 5 g in 1 TUBE (0832-1120-65) 30 tube2014-06-160000-00-00NoNoCurrent
0832-1120-350083211203530 PACKET in 1 CARTON (0832-1120-35) / 5 g in 1 PACKET (0832-1120-89) 30 packet2014-06-160000-00-00NoNoCurrent
0832-1120-65008321120655 g in 1 TUBE5 gHistorical
0832-1120-89008321120895 g in 1 PACKET5 gHistorical