jatenzo

Generic: testosterone undecanoate

Labeler: tolmar inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jatenzo
Generic Name testosterone undecanoate
Labeler tolmar inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

testosterone undecanoate 198 mg/1

Manufacturer
TOLMAR Inc.

Identifiers & Regulatory

Product NDC 69087-198
Product ID 69087-198_b62fac0e-07df-453f-b56a-bd94e5ee3336
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206089
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-08-01

Pharmacologic Class

Classes
androgen receptor agonists [moa] androgen [epc] androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69087198
Hyphenated Format 69087-198

Supplemental Identifiers

RxCUI
2121766 2121768 2121770 2121776 2201640 2201642
UNII
H16A5VCT9C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name jatenzo (source: ndc)
Generic Name testosterone undecanoate (source: ndc)
Application Number NDA206089 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 198 mg/1
source: ndc
Packaging
  • 12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69087-198-12 12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Ingredients (1)

testosterone undecanoate (198 mg/1)

Linked Drug Pages (1)

Jatenzo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b62fac0e-07df-453f-b56a-bd94e5ee3336", "openfda": {"unii": ["H16A5VCT9C"], "rxcui": ["2121766", "2121768", "2121770", "2121776", "2201640", "2201642"], "spl_set_id": ["ed7b5d41-7475-4c10-99b9-b62b3434ae60"], "manufacturer_name": ["TOLMAR Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BOTTLE, PLASTIC in 1 BOX (69087-198-12)  / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "69087-198-12", "marketing_start_date": "20190801"}], "brand_name": "Jatenzo", "product_id": "69087-198_b62fac0e-07df-453f-b56a-bd94e5ee3336", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "69087-198", "dea_schedule": "CIII", "generic_name": "testosterone undecanoate", "labeler_name": "TOLMAR Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jatenzo", "active_ingredients": [{"name": "TESTOSTERONE UNDECANOATE", "strength": "198 mg/1"}], "application_number": "NDA206089", "marketing_category": "NDA", "marketing_start_date": "20190801", "listing_expiration_date": "20261231"}