AndroGel

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerASCEND Therapeutics U.S., LLC

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1713952530
30 PACKET in 1 CARTON (17139-525-30) / 2.5 g in 1 PACKET

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

N021015

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": {
    "f4e8d29b-8707-4d47-e053-2a95a90aecee": {
      "match": "brand_token",
      "title": "ANDROGEL (TESTOSTERONE) GEL [ASCEND THERAPEUTICS U.S., LLC]",
      "spl_version": "130",
      "published_date": "2025-11-17"
    }
  },
  "productid": "17139-525_14a12387-5802-4ec9-8a75-85faebddd18c",
  "productndc": "17139-525",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "021015",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Feb 28, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 28, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Sep 26, 2003"
      }
    ],
    "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": "AndroGel",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA021015",
  "marketing_category": "NDA",
  "nonproprietary_name": "Testosterone",
  "start_marketing_date": "20230217",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G03BA03.

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