tenofovir disoproxil fumarate (69076-105)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler quinn pharmaceuticals

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Quinn Pharmaceuticals

Identifiers & Regulatory

Product NDC 69076-105

Product ID 69076-105_e2e54886-61f6-4b78-852f-50df5e0e63c9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209498

Listing Expiration 2026-12-31

Marketing Start 2020-01-01

Pharmacologic Class

Classes

hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc] nucleoside reverse transcriptase inhibitors [moa] nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69076105

Hyphenated Format 69076-105

Supplemental Identifiers

RxCUI

349251

UPC

0369076105034

UNII

OTT9J7900I

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 tenofovir disoproxil fumarate (source: ndc)

Generic Name tenofovir disoproxil fumarate (source: ndc)

Application Number ANDA209498 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, COATED in 1 BOTTLE, PLASTIC (69076-105-03)

source: ndc

Packages (1)

69076-105-03 30 TABLET, COATED in 1 BOTTLE, PLASTIC (69076-105-03)

Ingredients (1)

tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Tenofovir Disoproxil Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e2e54886-61f6-4b78-852f-50df5e0e63c9", "openfda": {"upc": ["0369076105034"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["92569e53-507e-7a5b-e053-2995a90aca35"], "manufacturer_name": ["Quinn Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (69076-105-03)", "package_ndc": "69076-105-03", "marketing_start_date": "20200101"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "69076-105_e2e54886-61f6-4b78-852f-50df5e0e63c9", "dosage_form": "TABLET, COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "69076-105", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "Quinn Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA209498", "marketing_category": "ANDA", "marketing_start_date": "20200101", "listing_expiration_date": "20261231"}