tenofovir disoproxil fumarate (42291-800)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler avkare

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-800

Product ID 42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090636

Listing Expiration 2027-12-31

Marketing Start 2019-01-10

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 42291800

Hyphenated Format 42291-800

Supplemental Identifiers

RxCUI

349251

UPC

0342291800304

UNII

OTT9J7900I

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 ANDA090636 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)

source: ndc

Packages (1)

42291-800-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)

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": "4875aee4-c75a-ee36-e063-6394a90a9ce8", "openfda": {"upc": ["0342291800304"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["7f0bc342-0a0a-1d28-e053-2991aa0a28b9"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)", "package_ndc": "42291-800-30", "marketing_start_date": "20190110"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8", "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": "42291-800", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA090636", "marketing_category": "ANDA", "marketing_start_date": "20190110", "listing_expiration_date": "20271231"}