emtricitabine and tenofovir disoproxil fumarate

Generic: emtricitabine and tenofovir disoproxil fumarate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name emtricitabine and tenofovir disoproxil fumarate
Generic Name emtricitabine and tenofovir disoproxil fumarate
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

emtricitabine 200 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-776
Product ID 71205-776_26719f78-0a87-4928-ab9f-7bb4665ba7c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090513
Listing Expiration 2026-12-31
Marketing Start 2021-03-30

Pharmacologic Class

Established (EPC)
human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205776
Hyphenated Format 71205-776

Supplemental Identifiers

RxCUI
476556
UPC
0371205776077
UNII
G70B4ETF4S OTT9J7900I
NUI
N0000175462 M0015066 N0000009947

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 emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Generic Name emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Application Number ANDA090513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (71205-776-03)
  • 7 TABLET, FILM COATED in 1 BOTTLE (71205-776-07)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-776-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-776-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-776-90)
source: ndc

Packages (5)

71205-776-03 3 TABLET, FILM COATED in 1 BOTTLE (71205-776-03) 71205-776-07 7 TABLET, FILM COATED in 1 BOTTLE (71205-776-07) 71205-776-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-776-30) 71205-776-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-776-60) 71205-776-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-776-90)

Ingredients (2)

emtricitabine (200 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Emtricitabine and Tenofovir Disoproxil Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26719f78-0a87-4928-ab9f-7bb4665ba7c2", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "upc": ["0371205776077"], "unii": ["G70B4ETF4S", "OTT9J7900I"], "rxcui": ["476556"], "spl_set_id": ["d3b849a7-219d-4acc-9e29-8f246cb4a7a9"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (71205-776-03)", "package_ndc": "71205-776-03", "marketing_start_date": "20241004"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (71205-776-07)", "package_ndc": "71205-776-07", "marketing_start_date": "20230315"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-776-30)", "package_ndc": "71205-776-30", "marketing_start_date": "20230315"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-776-60)", "package_ndc": "71205-776-60", "marketing_start_date": "20230315"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-776-90)", "package_ndc": "71205-776-90", "marketing_start_date": "20230315"}], "brand_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "product_id": "71205-776_26719f78-0a87-4928-ab9f-7bb4665ba7c2", "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]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]"], "product_ndc": "71205-776", "generic_name": "Emtricitabine and Tenofovir Disoproxil Fumarate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine and Tenofovir Disoproxil Fumarate", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "ANDA090513", "marketing_category": "ANDA", "marketing_start_date": "20210330", "listing_expiration_date": "20261231"}