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
0591292102
2 BOTTLE, PUMP in 1 CARTON (0591-2921-02) / 75 g in 1 BOTTLE, PUMP (0591-2921-18)

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

A076737

AB1AB1AB1

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": "TOPICAL",
  "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": "0591-2921_38f554a5-ee64-4429-96c5-52b02c7763c1",
  "productndc": "0591-2921",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "076737",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG/2.5GM PACKET",
        "product_no": "001",
        "approval_date": "Jan 27, 2006"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "50MG/5GM PACKET",
        "product_no": "002",
        "approval_date": "Jan 27, 2006"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "12.5MG/1.25GM ACTUATION",
        "product_no": "003",
        "approval_date": "Mar 9, 2015"
      }
    ],
    "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": "ANDA076737",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Testosterone",
  "start_marketing_date": "20151214",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G03BA03.

Access this data programmatically

Query Testosterone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs