NDC 70518-0568

Genvoya

Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide

Genvoya is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide Fumarate.

• Product ID: 70518-0568_7e53a8f9-1ac5-2777-e053-2a91aa0a9187
• NDC: 70518-0568
• Product Type: Human Prescription Drug
• Proprietary Name: Genvoya
• Generic Name: Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-06
• Marketing Category: NDA / NDA
• Application Number: NDA207561
• Labeler Name: REMEDYREPACK INC.
• Substance Name: ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
• Active Ingredient Strength: 150 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-0568-0

30 TABLET in 1 BLISTER PACK (70518-0568-0)

• Marketing Start Date: 2017-06-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0568-0 [70518056800]

Genvoya TABLET

• Marketing Category: NDA
• Application Number: NDA207561
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-06

Drug Details

Active Ingredients

Ingredient	Strength
ELVITEGRAVIR	150 mg/1

OpenFDA Data

• SPL SET ID: a22331e0-b0ea-47fa-a073-c60d175e652b
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 4GDQ854U53
  • LW2E03M5PG
  • G70B4ETF4S
  • FWF6Q91TZO
• RxNorm Concept Unique ID - RxCUI:
  • 1721613
  • 1721619

Pharmacological Class

• HIV Integrase Inhibitors [MoA]
• Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
• Cytochrome P450 2C9 Inducers [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]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]

NDC Crossover Matching brand name "Genvoya" or generic name "Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide"

NDC	Brand Name	Generic Name
50090-2279	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
70518-0568	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide