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United States · US · US:80603-105_413922db-74d9-ab1f-e063-6394a90aba28
Kyzatrex
In shortageOrange BookUNIISPLATC G03BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarius Pharmaceuticals
CountryUS (United States)
ATC codeG03BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11806031051190 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-11)
- ndc118060310522120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-22)
- ndc11806031053360 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-33)
Annotations
UNII (FDA Substance ID)
H16A5VCT9C
TESTOSTERONE UNDECANOATE
RxCUI 37864
Orange Book
N213953
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
"unii": {
"unii": "H16A5VCT9C",
"rxcui": "37864",
"inchikey": "UDSFVOAUHKGBEK-CNQKSJKFSA-N",
"display_name": "TESTOSTERONE UNDECANOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7f7167a7-2a25-47e2-acf5-33f499fce971": {
"match": "brand_token",
"title": "KYZATREX (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [MARIUS PHARMACEUTICALS]",
"spl_version": "22",
"published_date": "2025-11-17"
}
},
"productid": "80603-105_413922db-74d9-ab1f-e063-6394a90aba28",
"productndc": "80603-105",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "213953",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 27, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "002",
"approval_date": "Jul 27, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "Jul 27, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TESTOSTERONE UNDECANOATE",
"shortage_reason": "Testosterone Gel; Gel, Metered",
"shortage_status": "current",
"proprietary_name": "Kyzatrex",
"active_ingred_unit": "mg/1",
"application_number": "NDA213953",
"marketing_category": "NDA",
"nonproprietary_name": "TESTOSTERONE UNDECANOATE",
"start_marketing_date": "20220727",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G03BA.
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