FDA.reportPublic FDA data

Testosterone 12.5 mg

Manufacturer
Qualgen LLC
Effective date
2020-07-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:20:35

Label at a glance#

ProductTestosterone 12.5 mg
Active ingredientTESTOSTERONE
Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

testosterone 200mg pellet

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

T12.5 112-12T12.5 112-12

T12.5 112-30T12.5 112-30

res

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69761-11269761-112-12, 69761-112-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
TESTOSTERONE3XMK78S47OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cd012ade-c417-288c-e053-2a95a90a9d34d9b53f9d-3d0f-49ab-9bc1-5e1c1d26ed6a2021-10-04Exact identifier
spl set id: d9b53f9d-3d0f-49ab-9bc1-5e1c1d26ed6a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.