NDC 54436-200

XYOSTED

Testosterone Enanthate

XYOSTED is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Antares Pharma, Inc.. The primary component is Testosterone Enanthate.

• Product ID: 54436-200_0d4b9c23-b18f-4c4f-be87-f94d40529f3b
• NDC: 54436-200
• Product Type: Human Prescription Drug
• Proprietary Name: XYOSTED
• Generic Name: Testosterone Enanthate
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-11-15
• Marketing Category: NDA / NDA
• Application Number: NDA209863
• Labeler Name: Antares Pharma, Inc.
• Substance Name: TESTOSTERONE ENANTHATE
• Active Ingredient Strength: 100 mg/.5mL
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54436-200-01

1 SYRINGE in 1 CARTON (54436-200-01) > .5 mL in 1 SYRINGE (54436-200-03)

• Marketing Start Date: 2018-11-15
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 54436-200-03 [54436020003]

XYOSTED INJECTION

• Marketing Category: NDA
• Application Number: NDA209863
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-15

NDC 54436-200-04 [54436020004]

XYOSTED INJECTION

• Marketing Category: NDA
• Application Number: NDA209863
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-15

NDC 54436-200-01 [54436020001]

XYOSTED INJECTION

• Marketing Category: NDA
• Application Number: NDA209863
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-15

NDC 54436-200-02 [54436020002]

XYOSTED INJECTION

• Marketing Category: NDA
• Application Number: NDA209863
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-15

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE ENANTHATE	100 mg/.5mL

OpenFDA Data

• SPL SET ID: 8a3d204c-be26-49e0-8599-0ac12a272e81
• Manufacturer:
  • Antares Pharma, Inc.
• UNII:
  • 7Z6522T8N9
• RxNorm Concept Unique ID - RxCUI:
  • 2099681
  • 2099686
  • 2099689
  • 2099697
  • 2099695
  • 2099691

Pharmacological Class

• Androgen [EPC]
• Androgen Receptor Agonists [MoA]
• Androstanes [CS]

NDC Crossover Matching brand name "XYOSTED" or generic name "Testosterone Enanthate"

NDC	Brand Name	Generic Name
54436-200	XYOSTED	testosterone enanthate
54436-250	XYOSTED	testosterone enanthate
54436-275	XYOSTED	testosterone enanthate
0143-9750	TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE
0591-3221	Testosterone Enanthate	Testosterone Enanthate