FDA.reportPublic FDA data

testosterone

Product NDC
45802-610
11-digit product format
458020610
Labeler code
45802
Product ID
45802-610_49fac6b0-d016-4de8-a375-64de3e07aaa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA204255
Marketing category
ANDA
Marketing start
2017-06-28
Substance
TESTOSTERONE
Active strength
30 mg/1.5mL
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
TESTOSTERONE30 mg/1.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1599949

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
45802-610-01testosterone110 mL in 1 BOTTLE, PUMPSOLUTION11010
45802-610-01testosterone1 in 1 CARTONSOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-610-01ML - Milliliter45802-610f3422015-30be-461b-9871-774547db876112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-610TESTOSTERONE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 2 package rows20230316_c0c56607-e995-4bed-9c62-e33a722b38b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSNd22a072f-529b-4878-90fc-4365d9dc67e6106
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCDd22a072f-529b-4878-90fc-4365d9dc67e6106
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSYd22a072f-529b-4878-90fc-4365d9dc67e6106
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSYd22a072f-529b-4878-90fc-4365d9dc67e6106
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSYd22a072f-529b-4878-90fc-4365d9dc67e6106
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSN5be74193-de73-436d-a9a1-35a857bc8e0c105
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCD5be74193-de73-436d-a9a1-35a857bc8e0c105
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSY5be74193-de73-436d-a9a1-35a857bc8e0c105
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSY5be74193-de73-436d-a9a1-35a857bc8e0c105
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSY5be74193-de73-436d-a9a1-35a857bc8e0c105
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSNc0c56607-e995-4bed-9c62-e33a722b38b510
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCDc0c56607-e995-4bed-9c62-e33a722b38b510
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSYc0c56607-e995-4bed-9c62-e33a722b38b510
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSYc0c56607-e995-4bed-9c62-e33a722b38b510
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSYc0c56607-e995-4bed-9c62-e33a722b38b510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-610-01458020610011 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMP2017-06-280000-00-00NoNoCurrent