Testosterone

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

A209390

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Testosterone Gel; Gel, Metered

Raw payload (JSON)

{
  "unii": {
    "unii": "3XMK78S47O",
    "rxcui": "10379",
    "inchikey": "MUMGGOZAMZWBJJ-DYKIIFRCSA-N",
    "display_name": "TESTOSTERONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "28e8d504-5073-1d78-f351-bcb7c5188ee6": {
      "match": "brand_token",
      "title": "TESTOSTERONE GEL, METERED [XIROMED, LLC]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "24979-078_183542a9-eb31-4328-9c28-17264a898d03",
  "productndc": "24979-078",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "209390",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.62% (20.25MG/1.25GM ACTUATION)",
        "product_no": "001",
        "approval_date": "Sep 23, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "Testosterone",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA209390",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Testosterone",
  "start_marketing_date": "20191231",
  "active_numerator_strength": "16.2"
}

Related drugs

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