XYOSTED

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerAntares Pharma, Inc.

CountryUS (United States)

ATC codeG03BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5443620001
1 SYRINGE in 1 CARTON (54436-200-01) / .5 mL in 1 SYRINGE (54436-200-03)
ndc11
5443620004
4 SYRINGE in 1 CARTON (54436-200-04) / .5 mL in 1 SYRINGE (54436-200-02)
ndc11
5443620005
1 SYRINGE in 1 CARTON (54436-200-05) / .5 mL in 1 SYRINGE (54436-200-02)

Annotations

UNII (FDA Substance ID)

7Z6522T8N9

TESTOSTERONE ENANTHATE

RxCUI 37859

Orange Book

N209863

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Testosterone Gel; Gel, Metered

Raw payload (JSON)

{
  "unii": {
    "unii": "7Z6522T8N9",
    "rxcui": "37859",
    "inchikey": "VOCBWIIFXDYGNZ-IXKNJLPQSA-N",
    "display_name": "TESTOSTERONE ENANTHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "8a3d204c-be26-49e0-8599-0ac12a272e81": {
      "match": "brand_token",
      "title": "XYOSTED (TESTOSTERONE ENANTHATE) INJECTION [ANTARES PHARMA, INC.]",
      "spl_version": "16",
      "published_date": "2026-04-27"
    }
  },
  "productid": "54436-200_c8d74eb6-fa94-446a-8307-091436a536dc",
  "productndc": "54436-200",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209863",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/0.5ML (50MG/0.5ML)",
        "product_no": "001",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "75MG/0.5ML (75MG/0.5ML)",
        "product_no": "002",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/0.5ML (100MG/0.5ML)",
        "product_no": "003",
        "approval_date": "Sep 28, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE ENANTHATE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "XYOSTED",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA209863",
  "marketing_category": "NDA",
  "nonproprietary_name": "testosterone enanthate",
  "start_marketing_date": "20181115",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G03BA03.

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