testosterone

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerNorthstar Rx LLC

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1671496802
30 PACKET in 1 CARTON (16714-968-02) / 1.25 g in 1 PACKET (16714-968-01)

Annotations

UNII (FDA Substance ID)

3XMK78S47O

TESTOSTERONE

RxCUI 10379

Orange Book

A205781

AB2AB2

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": "16714-968_136b02e0-e440-45ea-9b1f-3ad58db0c710",
  "productndc": "16714-968",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "205781",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "1.62% (20.25MG/1.25GM PACKET)",
        "product_no": "001",
        "approval_date": "Jul 12, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB2",
        "strength": "1.62% (40.5MG/2.5GM PACKET)",
        "product_no": "002",
        "approval_date": "Jul 12, 2017"
      }
    ],
    "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/1.25g",
  "application_number": "ANDA205781",
  "marketing_category": "ANDA",
  "nonproprietary_name": "testosterone",
  "start_marketing_date": "20191106",
  "active_numerator_strength": "20.25"
}

Related drugs

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