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NDC 50072-0010-01 TPOXX 10 mg/mL Details
TPOXX 10 mg/mL
TPOXX is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by SIGA Technologies, Inc.. The primary component is TECOVIRIMAT.
Product Information
| NDC | 50072-0010 |
|---|---|
| Product ID | 50072-010_2cb13a6f-ca22-4756-9ad2-ed6a621baf0f |
| Associated GPIs | 12700090002030 |
| GCN Sequence Number | 083436 |
| GCN Sequence Number Description | tecovirimat VIAL 200MG/20ML INTRAVEN |
| HIC3 | W5A |
| HIC3 Description | ANTIVIRALS, GENERAL |
| GCN | 52394 |
| HICL Sequence Number | 045182 |
| HICL Sequence Number Description | TECOVIRIMAT |
| Brand/Generic | Brand |
| Proprietary Name | TPOXX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tecovirimat monohydrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | TECOVIRIMAT |
| Labeler Name | SIGA Technologies, Inc. |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA214518 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50072-0010-01 (50072001001)
| NDC Package Code | 50072-010-01 |
|---|---|
| Billing NDC | 50072001001 |
| Package | 7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30) |
| Marketing Start Date | 2022-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |