tenofovir disoproxil fumarate

Generic: tenofovir disoproxil fumarate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate
Generic Name tenofovir disoproxil fumarate
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-758
Product ID 50268-758_47fc8e5e-ba97-0118-e063-6394a90ad45c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090742
Listing Expiration 2027-12-31
Marketing Start 2020-03-30

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 50268758
Hyphenated Format 50268-758

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 ANDA090742 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX (50268-758-12) / 1 TABLET in 1 BLISTER PACK (50268-758-11)
source: ndc

Packages (1)

50268-758-12 20 BLISTER PACK in 1 BOX (50268-758-12) / 1 TABLET in 1 BLISTER PACK (50268-758-11)

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": "47fc8e5e-ba97-0118-e063-6394a90ad45c", "openfda": {"unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["a215f64c-84de-0649-e053-2a95a90a9d59"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX (50268-758-12)  / 1 TABLET in 1 BLISTER PACK (50268-758-11)", "package_ndc": "50268-758-12", "marketing_start_date": "20200330"}], "brand_name": "TENOFOVIR DISOPROXIL FUMARATE", "product_id": "50268-758_47fc8e5e-ba97-0118-e063-6394a90ad45c", "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": "50268-758", "generic_name": "tenofovir disoproxil fumarate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TENOFOVIR DISOPROXIL FUMARATE", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA090742", "marketing_category": "ANDA", "marketing_start_date": "20200330", "listing_expiration_date": "20271231"}