Jatenzo

In shortageOrange BookUNIISPLATC G03BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTOLMAR Inc.

CountryUS (United States)

ATC codeG03BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6908719812
12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 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": "69087-198_b62fac0e-07df-453f-b56a-bd94e5ee3336",
  "productndc": "69087-198",
  "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": "198"
}

Related drugs

Other records sharing ATC code G03BA.

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