xyosted

Generic: testosterone enanthate

Labeler: antares pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xyosted
Generic Name testosterone enanthate
Labeler antares pharma, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

testosterone enanthate 100 mg/.5mL

Manufacturer
Antares Pharma, Inc.

Identifiers & Regulatory

Product NDC 54436-200
Product ID 54436-200_5ceb96d9-1c9b-49e0-85a7-1ba393e276ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209863
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2018-11-15

Pharmacologic Class

Classes
androgen receptor agonists [moa] androgen [epc] androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54436200
Hyphenated Format 54436-200

Supplemental Identifiers

RxCUI
2099681 2099686 2099689 2099691 2099695 2099697
UNII
7Z6522T8N9

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xyosted (source: ndc)
Generic Name testosterone enanthate (source: ndc)
Application Number NDA209863 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (54436-200-01) / .5 mL in 1 SYRINGE (54436-200-03)
  • 4 SYRINGE in 1 CARTON (54436-200-04) / .5 mL in 1 SYRINGE (54436-200-02)
  • 1 SYRINGE in 1 CARTON (54436-200-05) / .5 mL in 1 SYRINGE (54436-200-02)
source: ndc

Packages (3)

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

Ingredients (1)

testosterone enanthate (100 mg/.5mL)

Linked Drug Pages (1)

XYOSTED ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "5ceb96d9-1c9b-49e0-85a7-1ba393e276ec", "openfda": {"unii": ["7Z6522T8N9"], "rxcui": ["2099681", "2099686", "2099689", "2099691", "2099695", "2099697"], "spl_set_id": ["8a3d204c-be26-49e0-8599-0ac12a272e81"], "manufacturer_name": ["Antares Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 SYRINGE in 1 CARTON (54436-200-01)  / .5 mL in 1 SYRINGE (54436-200-03)", "package_ndc": "54436-200-01", "marketing_start_date": "20181115"}, {"sample": false, "description": "4 SYRINGE in 1 CARTON (54436-200-04)  / .5 mL in 1 SYRINGE (54436-200-02)", "package_ndc": "54436-200-04", "marketing_start_date": "20181115"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (54436-200-05)  / .5 mL in 1 SYRINGE (54436-200-02)", "package_ndc": "54436-200-05", "marketing_start_date": "20240108"}], "brand_name": "XYOSTED", "product_id": "54436-200_5ceb96d9-1c9b-49e0-85a7-1ba393e276ec", "dosage_form": "INJECTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "54436-200", "dea_schedule": "CIII", "generic_name": "testosterone enanthate", "labeler_name": "Antares Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XYOSTED", "active_ingredients": [{"name": "TESTOSTERONE ENANTHATE", "strength": "100 mg/.5mL"}], "application_number": "NDA209863", "marketing_category": "NDA", "marketing_start_date": "20181115", "listing_expiration_date": "20261231"}