odefsey (61958-2101) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name odefsey

Generic Name emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide

Labeler gilead sciences, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

emtricitabine 200 mg/1, rilpivirine hydrochloride 25 mg/1, tenofovir alafenamide fumarate 25 mg/1

Manufacturer

Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-2101

Product ID 61958-2101_130b8bbc-f660-40ff-831c-139734f90b99

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA208351

Listing Expiration 2026-12-31

Marketing Start 2016-03-01

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 619582101

Hyphenated Format 61958-2101

Supplemental Identifiers

RxCUI

1741733 1741739

UNII

G70B4ETF4S 212WAX8KDD FWF6Q91TZO

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 odefsey (source: ndc)

Generic Name emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide (source: ndc)

Application Number NDA208351 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1
25 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

source: ndc

Packages (1)

61958-2101-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

Ingredients (3)

emtricitabine (200 mg/1) rilpivirine hydrochloride (25 mg/1) tenofovir alafenamide fumarate (25 mg/1)

Linked Drug Pages (1)

ODEFSEY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "130b8bbc-f660-40ff-831c-139734f90b99", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "212WAX8KDD", "FWF6Q91TZO"], "rxcui": ["1741733", "1741739"], "spl_set_id": ["ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5"], "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 (61958-2101-1)", "package_ndc": "61958-2101-1", "marketing_start_date": "20160301"}], "brand_name": "ODEFSEY", "product_id": "61958-2101_130b8bbc-f660-40ff-831c-139734f90b99", "dosage_form": "TABLET", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "61958-2101", "generic_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ODEFSEY", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "RILPIVIRINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "TENOFOVIR ALAFENAMIDE FUMARATE", "strength": "25 mg/1"}], "application_number": "NDA208351", "marketing_category": "NDA", "marketing_start_date": "20160301", "listing_expiration_date": "20261231"}