FDA.reportPublic FDA data

testosterone

Product NDC
45802-281
11-digit product format
458020281
Labeler code
45802
Product ID
45802-281_a7c10e20-f92f-4b14-a281-8118abfd4809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA205781
Marketing category
ANDA
Marketing start
2019-06-27
Substance
TESTOSTERONE
Active strength
20.25 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
TESTOSTERONE20.25 mg/1.25g

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
45802-281-03testosterone1.25 g in 1 PACKETGEL1.2514
45802-281-39testosterone30 in 1 CARTONGEL3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-281-03GM - Gram45802-281ce1f03de-1de6-4ea3-899e-81e9214a367a12019-09-05
45802-281-39GM - Gram45802-28197739956-d4f4-4e77-a2fc-2857282a7de712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-281TESTOSTERONE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 2 package rows20250427_54fcdcb9-fb0e-4164-9e51-f2a5feae3217.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN54fcdcb9-fb0e-4164-9e51-f2a5feae321714
1597120testosterone 1.62 % (20.25MG / 1.25GM) Transdermal GelPSN54fcdcb9-fb0e-4164-9e51-f2a5feae321714
1597126testosterone 1.62 % (40.5MG / 2.5GM) Transdermal GelPSN54fcdcb9-fb0e-4164-9e51-f2a5feae321714
15971201250 MG testosterone 0.0162 MG/MG Topical GelSCD54fcdcb9-fb0e-4164-9e51-f2a5feae321714
15971262500 MG testosterone 0.0162 MG/MG Topical GelSCD54fcdcb9-fb0e-4164-9e51-f2a5feae321714
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD54fcdcb9-fb0e-4164-9e51-f2a5feae321714
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY54fcdcb9-fb0e-4164-9e51-f2a5feae321714
1597120testosterone 1.62 % Transdermal Gel, 1.25 GMSY54fcdcb9-fb0e-4164-9e51-f2a5feae321714
1597126testosterone 1.62 % Transdermal Gel, 2.5 GMSY54fcdcb9-fb0e-4164-9e51-f2a5feae321714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-281-03458020281031.25 g in 1 PACKET1.25 gHistorical
45802-281-394580202813930 PACKET in 1 CARTON (45802-281-39) / 1.25 g in 1 PACKET (45802-281-03) 30 packet2019-06-270000-00-00NoNoCurrent