NDC 61958-2501

Biktarvy

Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate

Biktarvy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.

• Product ID: 61958-2501_033019c1-648b-4694-88dd-a56bd4899d5c
• NDC: 61958-2501
• Product Type: Human Prescription Drug
• Proprietary Name: Biktarvy
• Generic Name: Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-02-07
• Marketing Category: NDA / NDA
• Application Number: NDA210251
• Labeler Name: Gilead Sciences, Inc.
• Substance Name: BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1
• Pharm Classes: 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 61958-2501-1

30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1)

• Marketing Start Date: 2018-02-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61958-2501-2 [61958250102]

Biktarvy TABLET

• Marketing Category: NDA
• Application Number: NDA210251
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-26

NDC 61958-2501-1 [61958250101]

Biktarvy TABLET

• Marketing Category: NDA
• Application Number: NDA210251
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-07

Drug Details

Active Ingredients

Ingredient	Strength
BICTEGRAVIR SODIUM	50 mg/1

OpenFDA Data

• SPL SET ID: 664cb8f0-1f65-441b-b0d9-ba3d798be309
• Manufacturer:
  • Gilead Sciences, Inc.
• UNII:
  • 4L5MP1Y7W7
  • G70B4ETF4S
  • FWF6Q91TZO
• RxNorm Concept Unique ID - RxCUI:
  • 1999667
  • 1999673

Pharmacological Class

• 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

61958250101 BIKTARVY 50-200-25 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Biktarvy" or generic name "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate"

NDC	Brand Name	Generic Name
50090-6247	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
61958-2505	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
70518-3080	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate