tenofovir disoproxil fumarate

Generic: tenofovir disoproxil fumarate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate
Generic Name tenofovir disoproxil fumarate
Labeler bryant ranch prepack
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2364
Product ID 71335-2364_89290f33-955e-45fc-a481-ca4650cd125b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209498
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

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 713352364
Hyphenated Format 71335-2364

Supplemental Identifiers

RxCUI
349251
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 ANDA209498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-1)
  • 15 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-2)
source: ndc

Packages (2)

71335-2364-1 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-1) 71335-2364-2 15 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-2)

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": "89290f33-955e-45fc-a481-ca4650cd125b", "openfda": {"unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["3285f345-e58d-4831-a6a8-31094c8c546d"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-1)", "package_ndc": "71335-2364-1", "marketing_start_date": "20240430"}, {"sample": false, "description": "15 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-2364-2)", "package_ndc": "71335-2364-2", "marketing_start_date": "20240430"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "71335-2364_89290f33-955e-45fc-a481-ca4650cd125b", "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": "71335-2364", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "Bryant Ranch Prepack", "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": "20200101", "listing_expiration_date": "20261231"}