FDA.reportPublic FDA data

Androgel

Product NDC
0051-8450
11-digit product format
000518450
Labeler code
0051
Product ID
0051-8450_2e54dd8d-cf81-4c69-ad15-fa24f47dd3da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
AbbVie Inc.
Application
NDA021015
Marketing category
NDA
Marketing start
2011-03-14
Marketing end
2022-08-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0051-8450-01GM - Gram0051-84506b1fc40b-c55d-4f7c-a12e-6235e16530b512012-07-24
0051-8450-30GM - Gram0051-8450808604ec-7aa4-4ea6-b767-29dd9feaf43812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
testosteroneACTIVE INGREDIENT3XMK78S47OANDROGEL (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.]3
testosteroneACTIVE MOIETY3XMK78S47OANDROGEL (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.]3
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597074AndroGel 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSNd466910c-9a76-44e8-8759-4717ec2c591f3
1597124AndroGel 1 % (25MG / 2.5GM) Transdermal GelPSNd466910c-9a76-44e8-8759-4717ec2c591f3
1597130AndroGel 1 % (50MG / 5GM) Transdermal GelPSNd466910c-9a76-44e8-8759-4717ec2c591f3
1596780testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSNd466910c-9a76-44e8-8759-4717ec2c591f3
1597123testosterone 1 % (25 MG / 2.5 GM) Transdermal GelPSNd466910c-9a76-44e8-8759-4717ec2c591f3
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSNd466910c-9a76-44e8-8759-4717ec2c591f3
15971242500 MG testosterone 0.01 MG/MG Topical Gel [Androgel]SBDd466910c-9a76-44e8-8759-4717ec2c591f3
15971305000 MG testosterone 0.01 MG/MG Topical Gel [Androgel]SBDd466910c-9a76-44e8-8759-4717ec2c591f3
159707460 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel [Androgel]SBDd466910c-9a76-44e8-8759-4717ec2c591f3
15971232500 MG testosterone 0.01 MG/MG Topical GelSCDd466910c-9a76-44e8-8759-4717ec2c591f3
15971295000 MG testosterone 0.01 MG/MG Topical GelSCDd466910c-9a76-44e8-8759-4717ec2c591f3
159678060 ACTUAT testosterone 12.5 MG/ACTUAT Topical GelSCDd466910c-9a76-44e8-8759-4717ec2c591f3
15971242500 MG Androgel 0.01 MG/MG Topical GelSYd466910c-9a76-44e8-8759-4717ec2c591f3
15971305000 MG Androgel 0.01 MG/MG Topical GelSYd466910c-9a76-44e8-8759-4717ec2c591f3
1597074AndroGel 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSYd466910c-9a76-44e8-8759-4717ec2c591f3
1597124Androgel 1 % Transdermal Gel, 2.5 GMSYd466910c-9a76-44e8-8759-4717ec2c591f3
1597130Androgel 1 % Transdermal Gel, 5 GMSYd466910c-9a76-44e8-8759-4717ec2c591f3
1597123testosterone 1 % Transdermal Gel, 2.5 GMSYd466910c-9a76-44e8-8759-4717ec2c591f3
1596780testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUATSYd466910c-9a76-44e8-8759-4717ec2c591f3
1597129testosterone 50 MG Transdermal Gel, 5 GMSYd466910c-9a76-44e8-8759-4717ec2c591f3
1597130AndroGel 1 % (50MG / 5GM) Transdermal GelPSN77215d87-ad22-4169-bd5f-a453f10b21ef1
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN77215d87-ad22-4169-bd5f-a453f10b21ef1
15971305000 MG testosterone 0.01 MG/MG Topical Gel [Androgel]SBD77215d87-ad22-4169-bd5f-a453f10b21ef1
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD77215d87-ad22-4169-bd5f-a453f10b21ef1
15971305000 MG Androgel 0.01 MG/MG Topical GelSY77215d87-ad22-4169-bd5f-a453f10b21ef1
1597130Androgel 1 % Transdermal Gel, 5 GMSY77215d87-ad22-4169-bd5f-a453f10b21ef1
1597129testosterone 50 MG Transdermal Gel, 5 GMSY77215d87-ad22-4169-bd5f-a453f10b21ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0051-8450-300005184503030 PACKET in 1 CARTON (0051-8450-30) > 5 g in 1 PACKET (0051-8450-01) 30 packet2011-03-142022-08-31NoNoCurrent