tenofovir disoproxil fumarate (65862-820)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 250 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-820

Product ID 65862-820_ab772f55-3f84-41df-a84f-3a7035602cfd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090647

Listing Expiration 2026-12-31

Marketing Start 2018-01-26

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 65862820

Hyphenated Format 65862-820

Supplemental Identifiers

RxCUI

349251 1243227 1243324 1243328

UPC

0365862820303 0365862819307

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 ANDA090647 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1

source: ndc

Packaging

3 BLISTER PACK in 1 CARTON (65862-820-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE (65862-820-30)

source: ndc

Packages (2)

65862-820-03 3 BLISTER PACK in 1 CARTON (65862-820-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-820-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-820-30)

Ingredients (1)

tenofovir disoproxil fumarate (250 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": "ab772f55-3f84-41df-a84f-3a7035602cfd", "openfda": {"upc": ["0365862820303", "0365862819307"], "unii": ["OTT9J7900I"], "rxcui": ["349251", "1243227", "1243324", "1243328"], "spl_set_id": ["a75c6be8-3719-4bb3-8a9e-06e5254d2a82"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-820-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-820-03", "marketing_start_date": "20180126"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-820-30)", "package_ndc": "65862-820-30", "marketing_start_date": "20180126"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "65862-820_ab772f55-3f84-41df-a84f-3a7035602cfd", "dosage_form": "TABLET, FILM 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": "65862-820", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "250 mg/1"}], "application_number": "ANDA090647", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}