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United States · US · US:76420-746_1a9699dd-3fd3-2a4e-e063-6294a90aa662

Testosterone Cypionate

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7642074601
    1 VIAL, GLASS in 1 CARTON (76420-746-01) / 1 mL in 1 VIAL, GLASS
  • ndc11
    7642074610
    1 VIAL, GLASS in 1 CARTON (76420-746-10) / 10 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
M0XW1UBI14
TESTOSTERONE CYPIONATE
RxCUI 835827
Orange Book
A091244
AO
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
  "unii": {
    "unii": "M0XW1UBI14",
    "rxcui": "835827",
    "inchikey": "HPFVBGJFAYZEBE-ZLQWOROUSA-N",
    "display_name": "TESTOSTERONE CYPIONATE",
    "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": "76420-746_1a9699dd-3fd3-2a4e-e063-6294a90aa662",
  "productndc": "76420-746",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "091244",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "May 1, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE CYPIONATE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "Testosterone Cypionate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA091244",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Testosterone Cypionate",
  "start_marketing_date": "20190326",
  "active_numerator_strength": "200"
}

Related drugs

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