Depo-Testosterone

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerPharmacia & Upjohn Company LLC

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0009034702
1 VIAL in 1 CARTON (0009-0347-02) / 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": "0009-0347_6f9d26ce-7369-4283-97b0-fa06f187ac9c",
  "productndc": "0009-0347",
  "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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