NDC 50072-200

TPOXX

Tecovirimat Monohydrate

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 ID: 50072-200_638105d6-2895-4ab5-b1ef-3b5d95c196fa
• NDC: 50072-200
• Product Type: Human Prescription Drug
• Proprietary Name: TPOXX
• Generic Name: Tecovirimat Monohydrate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-31
• Marketing Category: NDA / NDA
• Application Number: NDA208627
• Labeler Name: SIGA Technologies, Inc.
• Substance Name: TECOVIRIMAT MONOHYDRATE
• Active Ingredient Strength: 200 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50072-200-42

42 CAPSULE in 1 BOTTLE (50072-200-42)

• Marketing Start Date: 2018-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50072-200-42 [50072020042]

TPOXX CAPSULE

• Marketing Category: NDA
• Application Number: NDA208627
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-31

Drug Details

Active Ingredients

Ingredient	Strength
TECOVIRIMAT MONOHYDRATE	200 mg/1

OpenFDA Data

• SPL SET ID: fce826ab-4d6a-4139-a2ee-a304a913a253
• Manufacturer:
  • SIGA Technologies, Inc.
• UNII:
  • SB96YO2BR8
• RxNorm Concept Unique ID - RxCUI:
  • 2055115
  • 2055109
• UPC Code:
  • 0350072200427

NDC Crossover Matching brand name "TPOXX" or generic name "Tecovirimat Monohydrate"

NDC	Brand Name	Generic Name
50072-010	TPOXX	tecovirimat monohydrate
50072-200	TPOXX	tecovirimat monohydrate