emtricitabine/tdf

Generic: emtricitabine/tdf

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name emtricitabine/tdf
Generic Name emtricitabine/tdf
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-403
Product ID 72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090513
Listing Expiration 2026-12-31
Marketing Start 2022-12-05

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 72189403
Hyphenated Format 72189-403

Supplemental Identifiers

RxCUI
476556
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/tdf (source: ndc)
Generic Name emtricitabine/tdf (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 (72189-403-03)
source: ndc

Packages (1)

72189-403-03 3 TABLET, FILM COATED in 1 BOTTLE (72189-403-03)

Ingredients (2)

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

Linked Drug Pages (1)

Emtricitabine/TDF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4cdf7a-45da-784b-e063-6294a90a82b9", "openfda": {"nui": ["N0000175462", "M0015066", "N0000009947"], "unii": ["G70B4ETF4S", "OTT9J7900I"], "rxcui": ["476556"], "spl_set_id": ["ef1a90ca-92bc-3787-e053-2a95a90a58ec"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (72189-403-03)", "package_ndc": "72189-403-03", "marketing_start_date": "20221205"}], "brand_name": "Emtricitabine/TDF", "product_id": "72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9", "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": "72189-403", "generic_name": "Emtricitabine/TDF", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emtricitabine/TDF", "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": "20221205", "listing_expiration_date": "20261231"}