biktarvy

Generic: bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name biktarvy
Generic Name bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bictegravir sodium 50 mg/1, emtricitabine 200 mg/1, tenofovir alafenamide fumarate 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6247
Product ID 50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210251
Listing Expiration 2026-12-31
Marketing Start 2018-02-07

Pharmacologic Class

Established (EPC)
human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906247
Hyphenated Format 50090-6247

Supplemental Identifiers

RxCUI
1999667 1999673
UNII
4L5MP1Y7W7 G70B4ETF4S FWF6Q91TZO
NUI
N0000175462 M0015066 N0000009947

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name biktarvy (source: ndc)
Generic Name bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate (source: ndc)
Application Number NDA210251 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 200 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)
source: ndc

Packages (1)

50090-6247-0 30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)

Ingredients (3)

bictegravir sodium (50 mg/1) emtricitabine (200 mg/1) tenofovir alafenamide fumarate (25 mg/1)

Linked Drug Pages (1)

Biktarvy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a3c4a0eb-71e8-4b35-9706-240874b78ee0", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["4L5MP1Y7W7", "G70B4ETF4S", "FWF6Q91TZO"], "rxcui": ["1999667", "1999673"], "spl_set_id": ["0476d7eb-1024-4821-bbe7-abaacfda32a2"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)", "package_ndc": "50090-6247-0", "marketing_start_date": "20221128"}], "brand_name": "Biktarvy", "product_id": "50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "50090-6247", "generic_name": "bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Biktarvy", "active_ingredients": [{"name": "BICTEGRAVIR SODIUM", "strength": "50 mg/1"}, {"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR ALAFENAMIDE FUMARATE", "strength": "25 mg/1"}], "application_number": "NDA210251", "marketing_category": "NDA", "marketing_start_date": "20180207", "listing_expiration_date": "20261231"}