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NDC 50072-0200-42 TPOXX 200 mg/1 Details
TPOXX 200 mg/1
TPOXX is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by SIGA Technologies, Inc.. The primary component is TECOVIRIMAT MONOHYDRATE.
Product Information
| NDC | 50072-0200 |
|---|---|
| Product ID | 50072-200_2cb13a6f-ca22-4756-9ad2-ed6a621baf0f |
| Associated GPIs | 12700090000120 |
| GCN Sequence Number | 078799 |
| GCN Sequence Number Description | tecovirimat CAPSULE 200 MG ORAL |
| HIC3 | W5A |
| HIC3 Description | ANTIVIRALS, GENERAL |
| GCN | 45193 |
| 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 | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | TECOVIRIMAT MONOHYDRATE |
| 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 | NDA208627 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50072-0200-42 (50072020042)
| NDC Package Code | 50072-200-42 |
|---|---|
| Billing NDC | 50072020042 |
| Package | 42 CAPSULE in 1 BOTTLE (50072-200-42) |
| Marketing Start Date | 2018-08-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |