FDA.reportPublic FDA data

Androgel

Product NDC
21695-112
11-digit product format
216950112
Labeler code
21695
Product ID
21695-112_77215d87-ad22-4169-bd5f-a453f10b21ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Rebel Distributors Corp.
Application
NDA021015
Marketing category
NDA
Marketing start
2003-06-05
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
10 mg/g
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-112-302019-09-24C16284748780-1934fe258-4b2d-48b1-e053-8cdaa90a720aAndrogel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-112-30Androgel30 in 1 CARTONGEL301
21695-112-30Androgel5 g in 1 PACKETGEL51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-112-30GM - Gram21695-1123c359deb-e9c0-4520-9eeb-299df3c9bded12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-112ANDROGEL (TESTOSTERONE) GEL [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20110314_77215d87-ad22-4169-bd5f-a453f10b21ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
21695-112-302169501123030 in 1 CARTONHistorical