tenofovir disoproxil fumarate (33342-096)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler macleods pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-096

Product ID 33342-096_9826ed5e-829c-4e94-9c60-761acb892d74

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203232

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 33342096

Hyphenated Format 33342-096

Supplemental Identifiers

RxCUI

349251

UPC

0333342096074

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 ANDA203232 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (33342-096-07)

source: ndc

Packages (1)

33342-096-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-096-07)

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": "9826ed5e-829c-4e94-9c60-761acb892d74", "openfda": {"upc": ["0333342096074"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["532755cb-1cd3-4774-97af-05a53779b65f"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-096-07)", "package_ndc": "33342-096-07", "marketing_start_date": "20180126"}], "brand_name": "tenofovir disoproxil fumarate", "product_id": "33342-096_9826ed5e-829c-4e94-9c60-761acb892d74", "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": "33342-096", "generic_name": "tenofovir disoproxil fumarate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tenofovir disoproxil fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA203232", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}