Testosterone

Product NDC
66993-952
11-digit product format
669930952
Labeler code
66993
Product ID
66993-952_b50198b2-d959-48cd-883d-3e1d30f9374b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Prasco Laboratories
Application
NDA022309
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-05-19
Substance
TESTOSTERONE
Active strength
16.2 mg/g
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
TESTOSTERONE16.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1597076, 1597126

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
66993-952-30Testosterone30 in 1 CARTONGEL304
66993-952-86Testosterone2.5 g in 1 PACKETGEL2.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-952-30GM - Gram66993-952f5a2ecf2-aa09-40ed-9641-5300e23bac6a12025-12-16
66993-952-86GM - Gram66993-9526cfed09e-3106-4e2f-abff-381b42776af812025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN0d84e5a6-11e9-4940-8991-21c611c4c32f4
1597126testosterone 1.62 % (40.5MG / 2.5GM) Transdermal GelPSN0d84e5a6-11e9-4940-8991-21c611c4c32f4
15971262500 MG testosterone 0.0162 MG/MG Topical GelSCD0d84e5a6-11e9-4940-8991-21c611c4c32f4
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD0d84e5a6-11e9-4940-8991-21c611c4c32f4
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY0d84e5a6-11e9-4940-8991-21c611c4c32f4
1597126testosterone 1.62 % Transdermal Gel, 2.5 GMSY0d84e5a6-11e9-4940-8991-21c611c4c32f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-952-306699309523030 PACKET in 1 CARTON (66993-952-30) / 2.5 g in 1 PACKET (66993-952-86) 30 packet2025-12-01NoNoCurrent
66993-952-86669930952862.5 g in 1 PACKET2.5 gHistorical