Depo-Testosterone

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7642042510
1 VIAL in 1 CARTON (76420-425-10) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

M0XW1UBI14

TESTOSTERONE CYPIONATE

RxCUI 835827

Orange Book

A085635

AOAO

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": {
    "cfbb53d4-b868-4a28-8436-f9112eb01c39": {
      "match": "brand_token",
      "title": "DEPO-TESTOSTERONE (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "25",
      "published_date": "2025-10-01"
    }
  },
  "productid": "76420-425_3d534b61-bcc6-9c44-e063-6294a90a1b6b",
  "productndc": "76420-425",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "085635",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AO",
        "strength": "100MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AO",
        "strength": "200MG/ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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": "Depo-Testosterone",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA085635",
  "marketing_category": "ANDA",
  "nonproprietary_name": "testosterone cypionate",
  "start_marketing_date": "19790725",
  "active_numerator_strength": "100"
}

Related drugs

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