NDC 70518-0714

PREZCOBIX

Darunavir Ethanolate And Cobicistat

PREZCOBIX is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Darunavir Ethanolate; Cobicistat.

• Product ID: 70518-0714_75b2e380-4617-96f5-e053-2991aa0ae9cc
• NDC: 70518-0714
• Product Type: Human Prescription Drug
• Proprietary Name: PREZCOBIX
• Generic Name: Darunavir Ethanolate And Cobicistat
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-28
• Marketing Category: NDA / NDA
• Application Number: NDA205395
• Labeler Name: REMEDYREPACK INC.
• Substance Name: DARUNAVIR ETHANOLATE; COBICISTAT
• Active Ingredient Strength: 800 mg/1; mg/1
• Pharm Classes: HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],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: 2019-12-31

Packaging

NDC 70518-0714-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0714-0)

• Marketing Start Date: 2017-08-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0714-0 [70518071400]

PREZCOBIX TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205395
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-28
• Marketing End Date: 2020-05-04

Drug Details

Active Ingredients

Ingredient	Strength
DARUNAVIR ETHANOLATE	800 mg/1

OpenFDA Data

• SPL SET ID: e4867e5d-aa52-4f6b-a998-a90203b3853e
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • LW2E03M5PG
  • 33O78XF0BW
• RxNorm Concept Unique ID - RxCUI:
  • 1600704
  • 1600710

Pharmacological Class

• HIV Protease Inhibitors [MoA]
• Protease Inhibitor [EPC]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• 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 Crossover Matching brand name "PREZCOBIX" or generic name "Darunavir Ethanolate And Cobicistat"

NDC	Brand Name	Generic Name
50090-1723	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT
70518-0714	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT