tenofovir disoproxil fumarate (71921-105)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler florida pharmaceutical products, llc.

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Florida Pharmaceutical Products, LLC.

Identifiers & Regulatory

Product NDC 71921-105

Product ID 71921-105_79278443-b9ee-4db6-ac15-a3d12b359eb0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209498

Listing Expiration 2026-12-31

Marketing Start 2025-11-26

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 71921105

Hyphenated Format 71921-105

Supplemental Identifiers

RxCUI

349251

UPC

0371921105335

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 (71921-105-33)

source: ndc

Packages (1)

71921-105-33 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71921-105-33)

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": "79278443-b9ee-4db6-ac15-a3d12b359eb0", "openfda": {"upc": ["0371921105335"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["0c7d72d6-bf80-49e0-921c-20169e87e62f"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (71921-105-33)", "package_ndc": "71921-105-33", "marketing_start_date": "20251126"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "71921-105_79278443-b9ee-4db6-ac15-a3d12b359eb0", "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": "71921-105", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "Florida Pharmaceutical Products, LLC.", "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": "20251126", "listing_expiration_date": "20261231"}