tenofovir disoproxil fumarate

Generic: tenofovir disoproxil fumarate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tenofovir disoproxil fumarate
Generic Name tenofovir disoproxil fumarate
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6821
Product ID 0904-6821_cc508ae9-cfcb-48f7-b742-a0d3eec666b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203232
Listing Expiration 2026-12-31
Marketing Start 2018-01-26

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 09046821
Hyphenated Format 0904-6821

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 ANDA203232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6821-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6821-04 30 BLISTER PACK in 1 CARTON (0904-6821-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "cc508ae9-cfcb-48f7-b742-a0d3eec666b6", "openfda": {"unii": ["OTT9J7900I"], "rxcui": ["349251"], "spl_set_id": ["da78a5d3-f5c6-47fe-b593-3252704c225d"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6821-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6821-04", "marketing_start_date": "20180126"}], "brand_name": "tenofovir disoproxil fumarate", "product_id": "0904-6821_cc508ae9-cfcb-48f7-b742-a0d3eec666b6", "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": "0904-6821", "generic_name": "tenofovir disoproxil fumarate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tenofovir disoproxil fumarate", "active_ingredients": [{"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA203232", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}