tenofovir disoproxil fumarate (16714-820)

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate

Generic Name tenofovir disoproxil fumarate

Labeler northstar rxllc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer

NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-820

Product ID 16714-820_eaeb1670-4e39-4541-8ff7-47057f3f5c36

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090636

Listing Expiration 2026-12-31

Marketing Start 2018-11-12

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 16714820

Hyphenated Format 16714-820

Supplemental Identifiers

RxCUI

349251

UPC

0316714820019

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 ANDA090636 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (16714-820-01)

source: ndc

Packages (1)

16714-820-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-820-01)

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": "eaeb1670-4e39-4541-8ff7-47057f3f5c36", "openfda": {"upc": ["0316714820019"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["eaeb1670-4e39-4541-8ff7-47057f3f5c36"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-820-01)", "package_ndc": "16714-820-01", "marketing_start_date": "20181112"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "16714-820_eaeb1670-4e39-4541-8ff7-47057f3f5c36", "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": "16714-820", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "NorthStar RxLLC", "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": "20181112", "listing_expiration_date": "20261231"}