testosterone cypionate

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerNorthStar Rx LLC

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7260328601
1 VIAL, SINGLE-DOSE in 1 CARTON (72603-286-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

M0XW1UBI14

TESTOSTERONE CYPIONATE

RxCUI 835827

Orange Book

A215351

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": "72603-286_3ba42272-97f6-0e87-e063-6394a90a2d9e",
  "productndc": "72603-286",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215351",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Apr 13, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "200MG/ML",
        "product_no": "002",
        "approval_date": "Apr 13, 2023"
      }
    ],
    "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": "ANDA215351",
  "marketing_category": "ANDA",
  "nonproprietary_name": "testosterone cypionate",
  "start_marketing_date": "20241101",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code G03BA03.

Access this data programmatically

Query testosterone cypionate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs