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 | 54436-250_0d4b9c23-b18f-4c4f-be87-f94d40529f3b |
NDC | 54436-250 |
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 | 50 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 |
Marketing Start Date | 2018-11-15 |
NDC Exclude Flag | N |
Sample Package? | Y |
Marketing Category | NDA |
Application Number | NDA209863 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2018-11-15 |
Marketing Category | NDA |
Application Number | NDA209863 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2018-11-15 |
Marketing Category | NDA |
Application Number | NDA209863 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2018-11-15 |
Marketing Category | NDA |
Application Number | NDA209863 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2018-11-15 |
Ingredient | Strength |
---|---|
TESTOSTERONE ENANTHATE | 50 mg/.5mL |
SPL SET ID: | 8a3d204c-be26-49e0-8599-0ac12a272e81 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XYOSTED 87190011 5740198 Live/Registered |
Antares Pharma Inc. 2016-09-30 |