FDA.reportPublic FDA data

testosterone

Product NDC
45802-754
11-digit product format
458020754
Labeler code
45802
Product ID
45802-754_a7c10e20-f92f-4b14-a281-8118abfd4809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA204268
Marketing category
ANDA
Marketing start
2018-10-12
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
45802-754-01testosterone88 g in 1 BOTTLE, PUMPGEL8814
45802-754-01testosterone1 in 1 CARTONGEL114
45802-754-02testosterone2.5 g in 1 PACKETGEL2.514
45802-754-03testosterone1.25 g in 1 PACKETGEL1.2514
45802-754-39testosterone1.25 g in 1 PACKETGEL1.2514
45802-754-39testosterone30 in 1 CARTONGEL3014
45802-754-65testosterone2.5 g in 1 PACKETGEL2.514
45802-754-65testosterone30 in 1 CARTONGEL3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-754-01GM - Gram45802-75489e547d3-d96c-4521-954f-77f0caf6f7b812018-11-06
45802-754-02GM - Gram45802-754e3f92643-3509-4cc5-a4ed-dbba774961e112018-11-06
45802-754-03GM - Gram45802-75453017feb-08b0-43dd-a405-6f3172bc98ac12018-11-06
45802-754-39GM - Gram45802-7543da8d6d5-b043-419e-9ac3-df25055d2a1212018-11-06
45802-754-65GM - Gram45802-75463cc0f2f-f270-4917-99c1-34ecaf582fe512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-754TESTOSTERONE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 8 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 ACTUATPSN78384754-5883-46b1-84e7-c063b4b4be82107
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD78384754-5883-46b1-84e7-c063b4b4be82107
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY78384754-5883-46b1-84e7-c063b4b4be82107
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN86254445-efd1-46d9-8236-3a0d98316f28101
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD86254445-efd1-46d9-8236-3a0d98316f28101
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY86254445-efd1-46d9-8236-3a0d98316f28101
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN9e10a37a-9c40-456b-a362-2fa8eae31e84100
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD9e10a37a-9c40-456b-a362-2fa8eae31e84100
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY9e10a37a-9c40-456b-a362-2fa8eae31e84100
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
45802-754-01458020754011 BOTTLE, PUMP in 1 CARTON (45802-754-01) / 88 g in 1 BOTTLE, PUMP2018-10-120000-00-00NoNoCurrent
45802-754-02458020754022.5 g in 1 PACKET2.5 gHistorical
45802-754-03458020754031.25 g in 1 PACKET (45802-754-03) 1.25 g2018-10-122021-04-01NoNoCurrent
45802-754-394580207543930 PACKET in 1 CARTON (45802-754-39) > 1.25 g in 1 PACKET30 packet2018-10-122021-04-01NoNoCurrent
45802-754-65458020754652.5 g in 1 PACKET2.5 gHistorical