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NDC 54436-0200-05 XYOSTED 100 mg/.5mL Details
XYOSTED 100 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 | 54436-0200 |
|---|---|
| Product ID | 54436-200_cb6917b9-70b7-45be-9f4e-b1c55938bf9b |
| Associated GPIs | 2310003020D540 |
| GCN Sequence Number | 079087 |
| GCN Sequence Number Description | testosterone enanthate AUTO INJCT 100 MG/0.5 SUBCUT |
| HIC3 | F1A |
| HIC3 Description | ANDROGENIC AGENTS |
| GCN | 45519 |
| 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 | 100 |
| 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 54436-0200-05 (54436020005)
| NDC Package Code | 54436-200-05 |
|---|---|
| Billing NDC | 54436020005 |
| Package | 1 SYRINGE in 1 CARTON (54436-200-05) / .5 mL in 1 SYRINGE (54436-200-02) |
| Marketing Start Date | 2024-01-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |