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United States · US · US:55150-336_87d5a456-b364-457b-a071-cfce20f0a780

TESTOSTERONE ENANTHATE

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeG03BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515033601
    1 VIAL, MULTI-DOSE in 1 CARTON (55150-336-01) / 5 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
7Z6522T8N9
TESTOSTERONE ENANTHATE
RxCUI 37859
Orange Book
A212659
AO
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
  "unii": {
    "unii": "7Z6522T8N9",
    "rxcui": "37859",
    "inchikey": "VOCBWIIFXDYGNZ-IXKNJLPQSA-N",
    "display_name": "TESTOSTERONE ENANTHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "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": "55150-336_87d5a456-b364-457b-a071-cfce20f0a780",
  "productndc": "55150-336",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212659",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "Feb 28, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE ENANTHATE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "TESTOSTERONE ENANTHATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212659",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TESTOSTERONE ENANTHATE",
  "start_marketing_date": "20240228",
  "active_numerator_strength": "200"
}

Related drugs

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