FDA.reportPublic FDA data

Testosterone

Product NDC
43853-0021
11-digit product format
438530021
Labeler code
43853
Product ID
43853-0021_ad415031-a6bb-4907-98eb-943b94424e84
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Baryta Carbonica, Carduus Mar, Damiana, Hamamelis Virg, Hepar, Korean Ginseng, Nuphar, Orchitinum, Phosphoricum Acidum, Populus Trem, Sabal Serulata, Selenium Metallicum, Testosterone.
Dosage form
LIQUID
Route
ORAL
Labeler
ProBlen
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-06-28
Marketing end
0000-00-00
Substance
AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; MILK THISTLE; TURNERA DIFFUSA LEAFY TWIG; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; ASIAN GINSENG; NUPHAR LUTEA ROOT; SUS SCROFA TESTICLE; PHOSPHORIC ACID; POPULUS TREMULOIDES LEAF; SAW PALMETTO; SELENIUM; TESTOSTERONE
Active strength
1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
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
43853-0021-12022-01-28C16284748780-19d75b9d0-c5f8-f424-e053-dadaa90a57ceProBLEN Testosterone
43853-0021-12020-10-05C16284748780-19d75b9d0-c5f8-f424-e053-dadaa90a57ceProBLEN Testosterone
43853-0021-12020-01-31C16284748780-19d75b9d0-c5f8-f424-e053-dadaa90a57ceProBLEN Testosterone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43853-0021-1Testosterone30 mL in 1 BOTTLE, SPRAYLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43853-0021TESTOSTERONE (AVENA SATIVA, BARYTA CARBONICA, CARDUUS MAR, DAMIANA, HAMAMELIS VIRG, HEPAR, KOREAN GINSENG, NUPHAR, ORCHITINUM, PHOSPHORICUM ACIDUM, POPULUS TREM, SABAL SERULATA, SELENIUM METALLICUM, TESTOSTERONE.) LIQUID [PROBLEN]2Legacy NDC, 1 package rows20201006_b6b5b283-4b7e-42ee-912c-63b32e1683e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43853-0021-14385300210130 mL in 1 BOTTLE, SPRAY (43853-0021-1) 30 ml2017-06-280000-00-00NoNoCurrent