FDA.reportPublic FDA data

Testosterone

Product NDC
70518-1171
11-digit product format
705181171
Labeler code
70518
Product ID
70518-1171_6c2bdcb4-6f4b-bebd-e053-2a91aa0ad09c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
NDA203098
Marketing category
NDA
Marketing start
2018-05-14
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
13 mg/1.25g
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
70518-1171-02025-11-11C16284748780-19d75b9d0-50c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TESTOSTERONE gel safely and effectively. See full prescribing information for TESTOSTERONE gel. TESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953
70518-1171-02020-01-31C16284748780-19d75b9d0-50c2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TESTOSTERONE gel safely and effectively. See full prescribing information for TESTOSTERONE gel. TESTOSTERONE gel, for topical use, CIII Initial U.S. Approval: 1953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1171TESTOSTERONE GEL [REMEDYREPACK INC.]1Legacy NDC20180514_fa29b98e-28a7-41f5-8fc7-718ea092de27.zip