Testosterone

Product NDC
69097-363
11-digit product format
690970363
Labeler code
69097
Product ID
69097-363_ce2732a6-d90e-442c-b7d0-dc1d65a7e3cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cipla USA Inc.
Application
ANDA209533
Marketing category
ANDA
Marketing start
2018-03-30
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
69097-363-44Testosterone90 mL in 1 BOTTLESOLUTION907
69097-363-44Testosterone1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-363-44ML - Milliliter69097-363668ba9e1-0c7e-4064-beb5-4ee61c8800a112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-363TESTOSTERONE SOLUTION [CIPLA USA INC.]5Current NDC, Legacy NDC, 2 package rows20250422_6a46b5de-5d95-4570-91a6-3e4278028c59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSN6a46b5de-5d95-4570-91a6-3e4278028c597
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCD6a46b5de-5d95-4570-91a6-3e4278028c597
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSY6a46b5de-5d95-4570-91a6-3e4278028c597
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSY6a46b5de-5d95-4570-91a6-3e4278028c597
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSY6a46b5de-5d95-4570-91a6-3e4278028c597

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-363-44690970363441 BOTTLE in 1 CARTON (69097-363-44) / 90 mL in 1 BOTTLE1 bottle2018-03-300000-00-00NoNoCurrent