FDA.reportPublic FDA data

AndroGel

Product NDC
17139-562
11-digit product format
171390562
Labeler code
17139
Product ID
17139-562_130cc5ce-2385-4630-a8a1-2767bb1e0575
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
ASCEND Therapeutics U.S., LLC
Application
NDA022309
Marketing category
NDA
Marketing start
2023-02-17
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
AndroGel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE16.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1597075, 1597076, 1597120, 1597121, 1597126, 1597127

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
17139-562-01AndroGel2.5 g in 1 PACKETGEL2.5130
17139-562-12AndroGel1.25 g in 1 PACKETGEL1.25130
17139-562-30AndroGel30 in 1 CARTONGEL30130
17139-562-31AndroGel30 in 1 CARTONGEL30130
17139-562-88AndroGel1 in 1 CARTONGEL1130
17139-562-88AndroGel88 g in 1 BOTTLE, PUMPGEL88130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17139-562-88GM - Gram17139-56279015b2a-83bb-4814-8376-1141ccc4acdb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17139-562ANDROGEL (TESTOSTERONE) GEL [ASCEND THERAPEUTICS U.S., LLC]128Current NDC, 6 package rows20240920_f4e8d29b-8707-4d47-e053-2a95a90aecee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597075AndroGel 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSNf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597121AndroGel 1.62 % (20.25MG / 1.25GM) Transdermal GelPSNf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597127AndroGel 1.62 % (40.5MG / 2.5GM) Transdermal GelPSNf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSNf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597120testosterone 1.62 % (20.25MG / 1.25GM) Transdermal GelPSNf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597126testosterone 1.62 % (40.5MG / 2.5GM) Transdermal GelPSNf4e8d29b-8707-4d47-e053-2a95a90aecee130
15971211250 MG testosterone 0.0162 MG/MG Topical Gel [Androgel]SBDf4e8d29b-8707-4d47-e053-2a95a90aecee130
15971272500 MG testosterone 0.0162 MG/MG Topical Gel [Androgel]SBDf4e8d29b-8707-4d47-e053-2a95a90aecee130
159707560 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel [Androgel]SBDf4e8d29b-8707-4d47-e053-2a95a90aecee130
15971201250 MG testosterone 0.0162 MG/MG Topical GelSCDf4e8d29b-8707-4d47-e053-2a95a90aecee130
15971262500 MG testosterone 0.0162 MG/MG Topical GelSCDf4e8d29b-8707-4d47-e053-2a95a90aecee130
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCDf4e8d29b-8707-4d47-e053-2a95a90aecee130
15971211250 MG Androgel 0.0162 MG/MG Topical GelSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
15971272500 MG Androgel 0.0162 MG/MG Topical GelSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597075AndroGel 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597121Androgel 1.62 % Transdermal Gel, 1.25 GMSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597127Androgel 1.62 % Transdermal Gel, 2.5 GMSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597120testosterone 1.62 % Transdermal Gel, 1.25 GMSYf4e8d29b-8707-4d47-e053-2a95a90aecee130
1597126testosterone 1.62 % Transdermal Gel, 2.5 GMSYf4e8d29b-8707-4d47-e053-2a95a90aecee130

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17139-562-01171390562012.5 g in 1 PACKET2.5 gHistorical
17139-562-12171390562121.25 g in 1 PACKET1.25 gHistorical
17139-562-301713905623030 in 1 CARTONHistorical
17139-562-311713905623130 in 1 CARTONHistorical
17139-562-88171390562881 BOTTLE, PUMP in 1 CARTON (17139-562-88) / 88 g in 1 BOTTLE, PUMP2023-02-17NoNoCurrent