Testosterone

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591292630
30 PACKET in 1 CARTON (0591-2926-30) / 2.5 g in 1 PACKET (0591-2926-25)

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

A204570

ABAB2AB2

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": "0591-2926_b63936d3-2d0c-4a45-8096-2d5c672e3819",
  "productndc": "0591-2926",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "204570",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.62% (20.25MG/1.25GM ACTUATION)",
        "product_no": "001",
        "approval_date": "Apr 10, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "1.62% (20.25MG/1.25GM PACKET)",
        "product_no": "002",
        "approval_date": "Jul 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "1.62% (40.5MG/2.5GM PACKET)",
        "product_no": "003",
        "approval_date": "Jul 17, 2020"
      }
    ],
    "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": "ANDA204570",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Testosterone",
  "start_marketing_date": "20210212",
  "active_numerator_strength": "16.2"
}

Related drugs

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