tenofovir disoproxil fumarate

Generic: tenofovir disoproxil fumarate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate
Generic Name tenofovir disoproxil fumarate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-361
Product ID 72789-361_40bb71ff-3881-bd53-e063-6394a90a38ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090636
Listing Expiration 2026-12-31
Marketing Start 2023-10-26

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 72789361
Hyphenated Format 72789-361

Supplemental Identifiers

RxCUI
349251
UPC
0372789361079
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
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-361-07)
source: ndc

Packages (1)

72789-361-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-361-07)

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": "40bb71ff-3881-bd53-e063-6394a90a38ef", "openfda": {"upc": ["0372789361079"], "unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["08a30772-02fc-4f63-e063-6394a90afd43"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-361-07)", "package_ndc": "72789-361-07", "marketing_start_date": "20231026"}], "brand_name": "Tenofovir Disoproxil Fumarate", "product_id": "72789-361_40bb71ff-3881-bd53-e063-6394a90a38ef", "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": "72789-361", "generic_name": "Tenofovir Disoproxil Fumarate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20231026", "listing_expiration_date": "20261231"}