NDC 59676-800

Symtuza

Darunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide

Symtuza is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Products Lp. The primary component is Darunavir; Cobicistat; Emtricitabine; Tenofovir Alafenamide.

• Product ID: 59676-800_1dbfe0fd-ca21-4637-b73b-75bb408cc0e4
• NDC: 59676-800
• Product Type: Human Prescription Drug
• Proprietary Name: Symtuza
• Generic Name: Darunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-17
• Marketing Category: NDA / NDA
• Application Number: NDA210455
• Labeler Name: Janssen Products LP
• Substance Name: DARUNAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
• Active Ingredient Strength: 800 mg/1; mg/1; 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],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: 2022-12-31

Packaging

NDC 59676-800-30

30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)

• Marketing Start Date: 2018-07-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-800-30 [59676080030]

Symtuza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210455
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-17

NDC 59676-800-99 [59676080099]

Symtuza TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210455
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-17

Drug Details

Active Ingredients

Ingredient	Strength
DARUNAVIR	800 mg/1

OpenFDA Data

• SPL SET ID: 85a17d00-6b7c-41ea-a6b3-5ad924820dab
• Manufacturer:
  • Janssen Products LP
• UNII:
  • LW2E03M5PG
  • YO603Y8113
  • EL9943AG5J
  • G70B4ETF4S
• RxNorm Concept Unique ID - RxCUI:
  • 2049671
  • 2049677
• UPC Code:
  • 0359676800309

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]
• 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]

Medicade Reported Pricing

59676080030 SYMTUZA 800-150-200-10 MG TAB

Pricing Unit: EA | Drug Type: