tenofovir disoproxil fumarate (69097-533)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler cipla usa inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-533

Product ID 69097-533_cee87535-9401-4baf-920c-7184d8959c09

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078800

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 69097533

Hyphenated Format 69097-533

Supplemental Identifiers

RxCUI

349251

UPC

0369097533021

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 ANDA078800 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (69097-533-02)
1000 TABLET in 1 BOTTLE (69097-533-15)

source: ndc

Packages (2)

69097-533-02 30 TABLET in 1 BOTTLE (69097-533-02) 69097-533-15 1000 TABLET in 1 BOTTLE (69097-533-15)

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": "cee87535-9401-4baf-920c-7184d8959c09", "openfda": {"upc": ["0369097533021"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["de27413a-6579-4586-80dc-39c712652952"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-533-02)", "package_ndc": "69097-533-02", "marketing_start_date": "20180126"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69097-533-15)", "package_ndc": "69097-533-15", "marketing_start_date": "20180126"}], "brand_name": "Tenofovir disoproxil fumarate", "product_id": "69097-533_cee87535-9401-4baf-920c-7184d8959c09", "dosage_form": "TABLET", "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": "69097-533", "generic_name": "Tenofovir disoproxil fumarate", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tenofovir disoproxil fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA078800", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}