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United States · US · US:69087-158_b62fac0e-07df-453f-b56a-bd94e5ee3336
Jatenzo
In shortageOrange BookUNIISPLATC G03BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTOLMAR Inc.
CountryUS (United States)
ATC codeG03BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11690871581212 BOTTLE, PLASTIC in 1 BOX (69087-158-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
H16A5VCT9C
TESTOSTERONE UNDECANOATE
RxCUI 37864
Orange Book
N206089
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": {
"ed7b5d41-7475-4c10-99b9-b62b3434ae60": {
"match": "brand_token",
"title": "JATENZO (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [TOLMAR INC.]",
"spl_version": "12",
"published_date": "2025-09-17"
}
},
"productid": "69087-158_b62fac0e-07df-453f-b56a-bd94e5ee3336",
"productndc": "69087-158",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "206089",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "158MG",
"product_no": "001",
"approval_date": "Mar 27, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "198MG",
"product_no": "002",
"approval_date": "Mar 27, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "237MG",
"product_no": "003",
"approval_date": "Mar 27, 2019"
}
],
"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": "Jatenzo",
"active_ingred_unit": "mg/1",
"application_number": "NDA206089",
"marketing_category": "NDA",
"nonproprietary_name": "testosterone undecanoate",
"start_marketing_date": "20190801",
"active_numerator_strength": "158"
}Related drugs
Other records sharing ATC code G03BA.
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