FDA.reportPublic FDA data

Testosterone

Product NDC
0591-2921
11-digit product format
005912921
Labeler code
0591
Product ID
0591-2921_38f554a5-ee64-4429-96c5-52b02c7763c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076737
Marketing category
ANDA
Marketing start
2015-12-14
Substance
TESTOSTERONE
Active strength
10 mg/g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
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
TESTOSTERONE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1596780, 1597123, 1597129

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
0591-2921-02Testosterone2 in 1 CARTONGEL221
0591-2921-18Testosterone75 g in 1 BOTTLE, PUMPGEL7521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2921-02GM - Gram0591-292164bf6606-4e07-4ca0-ae93-4717183ac83e12015-12-02
0591-2921-18GM - Gram0591-29216c72c9ec-5e44-4a7c-bcb8-8f3fcdab129912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MTESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ETESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RTESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2921TESTOSTERONE GEL [ACTAVIS PHARMA, INC.]18Current NDC, Legacy NDC, 2 package rows20230322_5834d34f-839d-412c-b74c-da1dad2cfa88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596780testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN5834d34f-839d-412c-b74c-da1dad2cfa8821
1597123testosterone 1 % (25 MG / 2.5 GM) Transdermal GelPSN5834d34f-839d-412c-b74c-da1dad2cfa8821
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN5834d34f-839d-412c-b74c-da1dad2cfa8821
15971232500 MG testosterone 0.01 MG/MG Topical GelSCD5834d34f-839d-412c-b74c-da1dad2cfa8821
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD5834d34f-839d-412c-b74c-da1dad2cfa8821
159678060 ACTUAT testosterone 12.5 MG/ACTUAT Topical GelSCD5834d34f-839d-412c-b74c-da1dad2cfa8821
1597123testosterone 1 % Transdermal Gel, 2.5 GMSY5834d34f-839d-412c-b74c-da1dad2cfa8821
1596780testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUATSY5834d34f-839d-412c-b74c-da1dad2cfa8821
1597129testosterone 50 MG Transdermal Gel, 5 GMSY5834d34f-839d-412c-b74c-da1dad2cfa8821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2921-02005912921022 BOTTLE, PUMP in 1 CARTON (0591-2921-02) / 75 g in 1 BOTTLE, PUMP (0591-2921-18) 2015-12-140000-00-00NoNoCurrent
0591-2921-180059129211875 g in 1 BOTTLE, PUMP75 gHistorical