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 · 2

ndc11
0832112005
30 TUBE in 1 CARTON (0832-1120-05) / 5 g in 1 TUBE (0832-1120-65)
ndc11
0832112035
30 PACKET in 1 CARTON (0832-1120-35) / 5 g in 1 PACKET (0832-1120-89)

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

N204399

AB2BX

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": "0832-1120_39853cd7-bfd1-848f-e063-6294a90a49e4",
  "productndc": "0832-1120",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "204399",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "50MG/5GM PACKET",
        "product_no": "002",
        "approval_date": "Jun 4, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "12.5MG/1.25GM ACTUATION",
        "product_no": "003",
        "approval_date": "Jun 4, 2014"
      }
    ],
    "appl_type": "N"
  },
  "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/5g",
  "application_number": "NDA204399",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Testosterone",
  "start_marketing_date": "20140616",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code G03BA03.

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