FDA.reportPublic FDA data

Testosterone

Product NDC
70700-112
11-digit product format
707000112
Labeler code
70700
Product ID
70700-112_690b4263-c351-3a6d-1817-5c41341fcf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL, METERED
Route
TRANSDERMAL
Labeler
Xiromed, LLC
Application
ANDA210835
Marketing category
ANDA
Marketing start
2020-05-08
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE20.25 mg/1.25g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O

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
70700-112-21Testosterone88 g in 1 BOTTLE, PUMPGEL, METERED886
70700-112-21Testosterone1 in 1 CARTONGEL, METERED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-112TESTOSTERONE GEL, METERED [XIROMED, LLC]5Current NDC, Legacy NDC, 2 package rows20220118_28e8d504-5073-1d78-f351-bcb7c5188ee6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN6c7d2dec-6492-4d53-b110-61ffeae9ee61104
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD6c7d2dec-6492-4d53-b110-61ffeae9ee61104
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY6c7d2dec-6492-4d53-b110-61ffeae9ee61104
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSNc6c0a39e-0e75-4356-a052-c26c30c76b26101
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCDc6c0a39e-0e75-4356-a052-c26c30c76b26101
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSYc6c0a39e-0e75-4356-a052-c26c30c76b26101
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN28e8d504-5073-1d78-f351-bcb7c5188ee67
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD28e8d504-5073-1d78-f351-bcb7c5188ee67
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY28e8d504-5073-1d78-f351-bcb7c5188ee67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70700-112-21707000112211 BOTTLE, PUMP in 1 CARTON (70700-112-21) / 88 g in 1 BOTTLE, PUMP2020-05-080000-00-00NoNoCurrent