truvada

Generic: emtricitabine and tenofovir disoproxil fumarate

Labeler: gilead sciences, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name truvada
Generic Name emtricitabine and tenofovir disoproxil fumarate
Labeler gilead sciences, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

emtricitabine 133 mg/1, tenofovir disoproxil fumarate 200 mg/1

Manufacturer
Gilead Sciences, Inc

Identifiers & Regulatory

Product NDC 61958-0704
Product ID 61958-0704_32422ee8-1cdc-4305-bb3e-0458472513fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021752
Listing Expiration 2026-12-31
Marketing Start 2016-03-10

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 619580704
Hyphenated Format 61958-0704

Supplemental Identifiers

RxCUI
476556 639888 1744001 1744003 1744005 1744007 1744009 1744011
UNII
OTT9J7900I G70B4ETF4S
NUI
N0000175462 M0015066 N0000009947

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 truvada (source: ndc)
Generic Name emtricitabine and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA021752 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 133 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0704-1)
source: ndc

Packages (1)

61958-0704-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0704-1)

Ingredients (2)

emtricitabine (133 mg/1) tenofovir disoproxil fumarate (200 mg/1)

Linked Drug Pages (1)

Truvada ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32422ee8-1cdc-4305-bb3e-0458472513fc", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["OTT9J7900I", "G70B4ETF4S"], "rxcui": ["476556", "639888", "1744001", "1744003", "1744005", "1744007", "1744009", "1744011"], "spl_set_id": ["54e82b13-a037-49ed-b4b3-030b37c0ecdd"], "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": ["Gilead Sciences, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0704-1)", "package_ndc": "61958-0704-1", "marketing_start_date": "20160310"}], "brand_name": "Truvada", "product_id": "61958-0704_32422ee8-1cdc-4305-bb3e-0458472513fc", "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": "61958-0704", "generic_name": "emtricitabine and tenofovir disoproxil fumarate", "labeler_name": "Gilead Sciences, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Truvada", "active_ingredients": [{"name": "EMTRICITABINE", "strength": "133 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "200 mg/1"}], "application_number": "NDA021752", "marketing_category": "NDA", "marketing_start_date": "20160310", "listing_expiration_date": "20261231"}