TESTOSTERONE CYPIONATE

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051845380
1 mL in 1 VIAL, GLASS (70518-4538-0)

Annotations

UNII (FDA Substance ID)

M0XW1UBI14

TESTOSTERONE CYPIONATE

RxCUI 835827

Orange Book

A210362

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": {
    "28e8d504-5073-1d78-f351-bcb7c5188ee6": {
      "match": "brand_token",
      "title": "TESTOSTERONE GEL, METERED [XIROMED, LLC]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70518-4538_464f2ad8-ef6f-717f-e063-6294a90a9b07",
  "productndc": "70518-4538",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "210362",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Jun 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "200MG/ML",
        "product_no": "002",
        "approval_date": "Jun 19, 2018"
      }
    ],
    "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": "ANDA210362",
  "marketing_category": "ANDA",
  "nonproprietary_name": "testosterone cypionate",
  "start_marketing_date": "20251217",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code G03BA03.

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