NDC 69189-1201

Stribild

Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate

Stribild is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate.

• Product ID: 69189-1201_ba8255c3-a4e3-4e8d-97bd-27c4b018c553
• NDC: 69189-1201
• Product Type: Human Prescription Drug
• Proprietary Name: Stribild
• Generic Name: Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-28
• Marketing Category: NDA / NDA
• Application Number: NDA203100
• Labeler Name: Avera McKennan Hospital
• Substance Name: ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL 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],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 Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 69189-1201-1

1 TABLET, FILM COATED in 1 DOSE PACK (69189-1201-1)

• Marketing Start Date: 2015-10-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69189-1201-1 [69189120101]

Stribild TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203100
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-10-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ELVITEGRAVIR	150 mg/1

OpenFDA Data

• SPL SET ID: 8ac4d501-7f05-426e-93be-a42240087b0c
• Manufacturer:
  • Avera McKennan Hospital
• UNII:
  • 4GDQ854U53
  • LW2E03M5PG
  • G70B4ETF4S
  • OTT9J7900I
• RxNorm Concept Unique ID - RxCUI:
  • 1306298
  • 1306292

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 "Stribild" or generic name "Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
50090-1318	Stribild	elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
53808-0887	Stribild	elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
61958-1201	Stribild	elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
69189-1201	Stribild	elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
70518-0674	Stribild	elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate