FDA.reportPublic FDA data

Vogelxo

Product NDC
0245-0872
11-digit product format
002450872
Labeler code
0245
Product ID
0245-0872_39e7ddfb-c092-4cb7-e063-6394a90a1d54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL, METERED
Route
TOPICAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA204399
Marketing category
NDA
Marketing start
2014-06-09
Substance
TESTOSTERONE
Active strength
12.5 mg/1
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
Vogelxo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3XMK78S47O
Rxcui1596780, 1596785, 1597129, 1597134

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
0245-0872-40Vogelxo60 in 1 BOTTLE, PUMPGEL, METERED6013
0245-0872-42Vogelxo2 in 1 CARTONGEL, METERED213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0872-40GM - Gram0245-087279f37aad-969e-4772-b670-05ad2019f4e412014-07-02
0245-0872-42GM - Gram0245-0872f06de64c-9daa-4f46-8aa3-11f7591c35f912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TestosteroneACTIVE INGREDIENT3XMK78S47OVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
TestosteroneACTIVE MOIETY3XMK78S47OVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36VOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
METHYL LAURATEINACTIVE INGREDIENT8IPS6BI6KWVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RVOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0872VOGELXO (TESTOSTERONE) GEL VOGELXO (TESTOSTERONE) GEL, METERED [UPSHER-SMITH LABORATORIES, LLC]12Current NDC, Legacy NDC, 2 package rows20221217_2dd150f6-cdfd-4d51-8888-12b288f26262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596780testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN2dd150f6-cdfd-4d51-8888-12b288f2626213
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN2dd150f6-cdfd-4d51-8888-12b288f2626213
1596785Vogelxo 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN2dd150f6-cdfd-4d51-8888-12b288f2626213
1597134Vogelxo 1 % (50MG / 5GM) Transdermal Gel, 5 GMPSN2dd150f6-cdfd-4d51-8888-12b288f2626213
15971345000 MG testosterone 0.01 MG/MG Topical Gel [Vogelxo]SBD2dd150f6-cdfd-4d51-8888-12b288f2626213
159678560 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel [Vogelxo]SBD2dd150f6-cdfd-4d51-8888-12b288f2626213
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD2dd150f6-cdfd-4d51-8888-12b288f2626213
159678060 ACTUAT testosterone 12.5 MG/ACTUAT Topical GelSCD2dd150f6-cdfd-4d51-8888-12b288f2626213
15971345000 MG Vogelxo 0.01 MG/MG Topical GelSY2dd150f6-cdfd-4d51-8888-12b288f2626213
1596780testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUATSY2dd150f6-cdfd-4d51-8888-12b288f2626213
1597129testosterone 50 MG Transdermal Gel, 5 GMSY2dd150f6-cdfd-4d51-8888-12b288f2626213
1596785Vogelxo 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUATSY2dd150f6-cdfd-4d51-8888-12b288f2626213
1597134Vogelxo 50 MG Transdermal Gel, 5 GMSY2dd150f6-cdfd-4d51-8888-12b288f2626213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0245-0872-400024508724060 in 1 BOTTLE, PUMPHistorical
0245-0872-42002450872422 BOTTLE, PUMP in 1 CARTON (0245-0872-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0245-0872-40) 2014-06-090000-00-00NoNoCurrent