FDA.reportPublic FDA data

Testosterone

Product NDC
0591-2924
11-digit product format
005912924
Labeler code
0591
Product ID
0591-2924_b63936d3-2d0c-4a45-8096-2d5c672e3819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204570
Marketing category
ANDA
Marketing start
2019-04-10
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, 1597120, 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
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
0591-2924-18Testosterone1 in 1 CARTONGEL111
0591-2924-18Testosterone88 g in 1 BOTTLE, PUMPGEL8811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2924-18GM - Gram0591-292450330ef5-7969-441b-9843-d7f84b2925fd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2924TESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20210213_4f3c2c0a-7dab-4b50-9cae-869c3c2a8498.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597120testosterone 1.62 % (20.25MG / 1.25GM) Transdermal GelPSN4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597126testosterone 1.62 % (40.5MG / 2.5GM) Transdermal GelPSN4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
15971201250 MG testosterone 0.0162 MG/MG Topical GelSCD4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
15971262500 MG testosterone 0.0162 MG/MG Topical GelSCD4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597120testosterone 1.62 % Transdermal Gel, 1.25 GMSY4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597126testosterone 1.62 % Transdermal Gel, 2.5 GMSY4f3c2c0a-7dab-4b50-9cae-869c3c2a849811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2924-18005912924181 BOTTLE, PUMP in 1 CARTON (0591-2924-18) / 88 g in 1 BOTTLE, PUMP2019-04-100000-00-00NoNoCurrent