Testosterone Gel, 1%

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7216212743
30 PACKET in 1 CARTON (72162-1274-3) / 5 g in 1 PACKET

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

A212984

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": "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": "72162-1274_83a7397d-3e1e-46e2-b19d-de0ea1c75789",
  "productndc": "72162-1274",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "212984",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "50MG/5GM PACKET",
        "product_no": "001",
        "approval_date": "Nov 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "12.5MG/1.25GM ACTUATION",
        "product_no": "002",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG/2.5GM PACKET",
        "product_no": "003",
        "approval_date": "Jul 11, 2024"
      }
    ],
    "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 Gel, 1%",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA212984",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Testosterone Gel, 1%",
  "start_marketing_date": "20210110",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G03BA03.

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