Home NDC 0378-5440 Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Product NDC 0378-5440
11-digit product format 003785440
Labeler code 0378
Product ID 0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA208452
Marketing category ANDA
Marketing start 2025-05-27
Substance EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200; 25; 300 mg/1; mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208452-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208452-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2025-05-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208452-001 PC 2025-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208452-001 PC 2025-11-23 6a471c1ec25d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 200 mg/1 RILPIVIRINE HYDROCHLORIDE 25 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup 212WAX8KDD Internal UNII lookup OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147334 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-5440-77 Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1 0378-5440-93 Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0378-5440-77 00378544077 90 in 1 BOTTLE, PLASTIC Historical 0378-5440-93 00378544093 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93) 2025-05-27 No No Current