NDC 61958-1401

Tybost

Cobicistat

Tybost is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Cobicistat.

• Product ID: 61958-1401_16173cc7-61d5-4799-8179-cfee29687e28
• NDC: 61958-1401
• Product Type: Human Prescription Drug
• Proprietary Name: Tybost
• Generic Name: Cobicistat
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-24
• Marketing Category: NDA / NDA
• Application Number: NDA203094
• Labeler Name: Gilead Sciences, Inc.
• Substance Name: COBICISTAT
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61958-1401-1

30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1)

• Marketing Start Date: 2014-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61958-1401-1 [61958140101]

Tybost TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203094
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-24

Drug Details

Active Ingredients

Ingredient	Strength
COBICISTAT	150 mg/1

OpenFDA Data

• SPL SET ID: 3784c35c-e87f-410c-900b-8fd6313c6010
• Manufacturer:
  • Gilead Sciences, Inc.
• UNII:
  • LW2E03M5PG
• RxNorm Concept Unique ID - RxCUI:
  • 1551999
  • 1551993
• UPC Code:
  • 0361958140119

Pharmacological Class

• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 3A Inhibitor [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]