FDA.reportPublic FDA data

Testosterone

Product NDC
66993-953
11-digit product format
669930953
Labeler code
66993
Product ID
66993-953_c9fee58e-0843-4cf3-8d60-c578dc9a288f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Prasco Laboratories
Application
NDA021015
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-05-19
Substance
TESTOSTERONE
Active strength
12.5 mg/1.25g
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
TESTOSTERONE12.5 mg/1.25g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1596780, 1597123, 1597129

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
66993-953-44Testosterone2 in 1 CARTONGEL23
66993-953-88Testosterone88 g in 1 BOTTLE, PUMPGEL883

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-953-44GM - Gram66993-9532edb02f3-085a-417e-85ff-e65516a0b8c312025-06-13
66993-953-88GM - Gram66993-9530b825073-ba65-49ac-9852-8a2931b10ec312025-06-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596780testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN68b2375d-0365-4797-bc3d-63531c9f42fd3
1597123testosterone 1 % (25 MG / 2.5 GM) Transdermal GelPSN68b2375d-0365-4797-bc3d-63531c9f42fd3
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN68b2375d-0365-4797-bc3d-63531c9f42fd3
15971232500 MG testosterone 0.01 MG/MG Topical GelSCD68b2375d-0365-4797-bc3d-63531c9f42fd3
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD68b2375d-0365-4797-bc3d-63531c9f42fd3
159678060 ACTUAT testosterone 12.5 MG/ACTUAT Topical GelSCD68b2375d-0365-4797-bc3d-63531c9f42fd3
1597123testosterone 1 % Transdermal Gel, 2.5 GMSY68b2375d-0365-4797-bc3d-63531c9f42fd3
1596780testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUATSY68b2375d-0365-4797-bc3d-63531c9f42fd3
1597129testosterone 50 MG Transdermal Gel, 5 GMSY68b2375d-0365-4797-bc3d-63531c9f42fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-953-44669930953442 BOTTLE, PUMP in 1 CARTON (66993-953-44) / 88 g in 1 BOTTLE, PUMP (66993-953-88) 2025-05-19NoNoCurrent
66993-953-886699309538888 g in 1 BOTTLE, PUMP88 gHistorical