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United States · US · US:72162-1421_78ca5df2-0a66-41fe-9f28-4ba270cfce81

testosterone

In shortageOrange BookUNIISPLATC G03BA03

Last synced from FDA National Drug Code directory (United States) on

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
    7216214212
    1 BOTTLE, PUMP in 1 CARTON (72162-1421-2) / 110 mL in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A204255
AT
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": "72162-1421_78ca5df2-0a66-41fe-9f28-4ba270cfce81",
  "productndc": "72162-1421",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "204255",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "30MG/1.5ML ACTUATION",
        "product_no": "001",
        "approval_date": "Feb 28, 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/1.5mL",
  "application_number": "ANDA204255",
  "marketing_category": "ANDA",
  "nonproprietary_name": "testosterone",
  "start_marketing_date": "20170628",
  "active_numerator_strength": "30"
}

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