Testosterone

Product NDC
0591-2363
11-digit product format
005912363
Labeler code
0591
Product ID
0591-2363_a4201616-9b08-42e3-b0de-bf8354152d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL, METERED
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204571
Marketing category
ANDA
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
10 mg/.5g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0591-2363-60GM - Gram0591-2363c88954f3-c168-4d9c-9336-ec6bfc8a31eb12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2363TESTOSTERONE GEL, METERED [ACTAVIS PHARMA, INC.]15Legacy NDC20250312_415057d5-8ed3-42dd-9637-05145c84a9c2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2363-60005912363601 CANISTER in 1 CARTON (0591-2363-60) > 60 g in 1 CANISTER1 canister2015-06-010000-00-00NoNoCurrent