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NDC 54436-0275-01 XYOSTED 75 mg/.5mL Details
XYOSTED 75 mg/.5mL
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 Information
NDC | 54436-0275 |
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Product ID | 54436-275_cb6917b9-70b7-45be-9f4e-b1c55938bf9b |
Associated GPIs | 2310003020D530 |
GCN Sequence Number | 079085 |
GCN Sequence Number Description | testosterone enanthate AUTO INJCT 75MG/0.5ML SUBCUT |
HIC3 | F1A |
HIC3 Description | ANDROGENIC AGENTS |
GCN | 45517 |
HICL Sequence Number | 001401 |
HICL Sequence Number Description | TESTOSTERONE ENANTHATE |
Brand/Generic | Brand |
Proprietary Name | XYOSTED |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | testosterone enanthate |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 75 |
Active Ingredient Units | mg/.5mL |
Substance Name | TESTOSTERONE ENANTHATE |
Labeler Name | Antares Pharma, Inc. |
Pharmaceutical Class | Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS] |
DEA Schedule | CIII |
Marketing Category | NDA |
Application Number | NDA209863 |
Listing Certified Through | 2025-12-31 |
Package
NDC 54436-0275-01 (54436027501)
NDC Package Code | 54436-275-01 |
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Billing NDC | 54436027501 |
Package | 1 SYRINGE in 1 CARTON (54436-275-01) / .5 mL in 1 SYRINGE (54436-275-03) |
Marketing Start Date | 2018-11-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |