biktarvy

Generic: bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate

Labeler: gilead sciences, inc.
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 gilead sciences, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-2501
Product ID 61958-2501_239a890e-57db-430c-897a-11a7eb9a3611
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210251
Listing Expiration 2027-12-31
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 619582501
Hyphenated Format 61958-2501

Supplemental Identifiers

RxCUI
1999667 1999673 2584354 2584356
UNII
FWF6Q91TZO G70B4ETF4S 4L5MP1Y7W7
NUI
N0000175462 M0015066 N0000009947

Packaging Origin

Original Packager
true

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 (61958-2501-1)
  • 7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2)
  • 30 TABLET in 1 BLISTER PACK (61958-2501-3)
source: ndc

Packages (3)

61958-2501-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1) 61958-2501-2 7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2) 61958-2501-3 30 TABLET in 1 BLISTER PACK (61958-2501-3)

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": "239a890e-57db-430c-897a-11a7eb9a3611", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["FWF6Q91TZO", "G70B4ETF4S", "4L5MP1Y7W7"], "rxcui": ["1999667", "1999673", "2584354", "2584356"], "spl_set_id": ["664cb8f0-1f65-441b-b0d9-ba3d798be309"], "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": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1)", "package_ndc": "61958-2501-1", "marketing_start_date": "20180207"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2)", "package_ndc": "61958-2501-2", "marketing_start_date": "20180726"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (61958-2501-3)", "package_ndc": "61958-2501-3", "marketing_start_date": "20210824"}], "brand_name": "Biktarvy", "product_id": "61958-2501_239a890e-57db-430c-897a-11a7eb9a3611", "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": "61958-2501", "generic_name": "bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate", "labeler_name": "Gilead Sciences, Inc.", "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": "20271231"}